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Classification of newly notified Medical Devices

S. No.Notified CategoryIntended UseRisk Class

1.

CT scan EquipmentUse of x-ray source and digitally scanned computer technology to create cross-sectional images of the body.Class C

2.

MRI

Equipment

It is a medical imaging procedure using radio waves, magnetic fields, and magnetic field gradients to generate images of organs in the body.

Class C

3.

Defibrillators

It is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and delivers an electrical shock to the heart for restoring the normal rhythm of heart.

Class C

4.

Dialysis MachineIt is used for acute or chronic kidney failure that filters blood to remove excess water and waste products.

Class C

5.

PET

Equipment

Intended to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs.

Class C

6.

X-Ray Machine

Use of X-rays to diagnose or treat patients by imaging the internal structure of the body to assess the abnormalities in the body.

Class C

7.

Bone marrow cell separatorIt is a general lab equipment to be used to isolate target cells and cells concentrate from bone and blood.

Class B

8.

NebulizerIt is device used to administer medications in the form of mist to inhale for respiratory disorders.Class C

9.

Blood Pressure Monitoring DevicesIt is device used to measure the diastolic and systolic blood pressures.

Class B

10.

Digital ThermometerIt is device used to record the body temperature.Class B

11.

*GlucometerIt is a device used to measure the concentration of glucose in blood.Class C

12.

Organ Preservative SolutionSolution for hypothermic flushing, storage and transport of organs and to maintain the organ vitality during transplant into human recipients.

Class C

* Glucometer will be regulated under IVD category

 

Notice

File No. 29/Misc/3/2018-DC(18) Date: 16.08.2018

In continuation to the earlier Notice vide File No: 29/Misc./3/2017-DC(292) dated 01.11.2017 and amended classification list dated 06.06.2018 regarding Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, the following Medical Devices have been added in the annexure I :

S. No.Notified CategoryDevice nameGeneral Intended UseRisk Class
1.Surgical DressingsSuture Anchor (Spartan PEEK Suture Implant)Soft Tissue RepairC
2.Disposable Hypodermic NeedlesSpecial bevelled needles for implantable vascular access systemPower – injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. It is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the needle is also indicated for power injection of contrast media.C
3.Internal Prosthetic ReplacementsAuditory Brainstem Implant SystemAn auditory brain stem implant is a small device that is surgically implanted in the brain of a deaf person whose auditory nerves is lacking or damaged. The auditory nerves conduct the sound signals from the ear to the brain. The implant enables otherwise the deaf people to have a sensation of hearing.D
4.Surgical DressingsSternal fixation Reconstructive implantSternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.C
5.Internal Prosthetic ReplacementsDural Graft ImplantDural Graft Implant is intended for use in procedures where the repair or substitution of the patient’s dura mater is needed.C
6.CathetersImplantable infusion pumps with CathetersIntended to treat chronic pain and spasticity patients. The pump is inserted below the ribs and it designed to continually transport medication to the site of action. Doses are accurate, user friendly and the device does not restrict movement.D
7.CathetersLaser SheathIntended for use as adjuncts to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulationC
8.Internal Prosthetic ReplacementsGluteus implantsImplant for augmentation of buttocksC
9.Internal Prosthetic ReplacementsCalf implantsImplant for augmentation of CalfC
10.Blood BagsBlood bags without anticoagulantIt is indicated for the collection of human blood and the preservation of blood components.C
11.Blood BagsBlood bags with anticoagulantIt is indicated for the collection of human blood and the preservation of blood components.C
12.CathetersTrocarsA trocar is made up of an obturator (which may be a metal or plastic sharpened or non-bladed tip), a cannula(basically a hollow tube), and a seal. The trocar functions as a portal for the subsequent placement of other instruments, such as graspers, scissors, staplers, etc. It is also intended to remove air or fluid for the pleural space in a closed, one way fashion.B
13.CathetersUreteral stentIndicated to relieve obstructions in variety of benign, malignant and post- traumatic condition in the ureter. These conditions include stones and/or stone fragments or other Ureteral obstructions such as those associated with ureteral strictures, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma or in association with the Extracoporeal Shock wave lithotripsy (ESWL). The stent may be placed using endoscopic or percutaneously using standard or radiographic technique.C
14.Heart ValvesTranscatheter Heart ValveIt is intended for people with symptomatic aortic stenosis who are considered an intermediate or high risk patient for standard valve replacement surgery.D
15.Surgical DressingsLiquid bandagePrevention of injection by limiting exposure to dirt and germs in case of minor cuts, abrasions and blisters.B
16.Disposable Perfusion SetsHemoconcentrator setA hemoconcentrator is a fluid removal device used during cardio bypass surgery. The device is inserted into the extracorpeal circuit where it acts to control hemodilution, maintain hematocrit levels and reduce the need for additional blood products during and after surgery.C
17.Disposable Perfusion SetsApheresis KitIntended for the collection and separation of blood componentsC
18.Disposable Perfusion SetsBlood Filter SystemIntended for collection and preparation of various blood componentsC
19.Internal Prosthetic ReplacementsInjectable implant for the treatment of vesicoureteral refluxTreatment of vesicoureteral refluxC
20.Surgical DressingsBone wax/HaemostatTo stop bleeding at bones in orthopaedics and traumatology, thoracic surgery, dental, oral jaw surgery, neurosurgery.C
21.Disposable Hypodermic SyringesHyaluronic acid (cross linked) Pre-filled syringeFor intradermal implantation and facial soft tissue augmentation.C
22.Disposable Hypodermic SyringesCrosslinked sodium hyaluronateIt is indicated as viscoelastic supplement or a replacement for synovial fluid in human joints. It is suited for treatment of symptoms of human joint dysfunctions such as osteoarthritis. The actions of the product are lubrication and mechanical support.C
23.Disposable Hypodermic SyringesHyaluronic acid with Lidocaine (cross linked) Pre-filled syringeIt is indicated for the treatment of fine lines and medium sized skin depressions and correcting infraorbital skin depressions via deep injectionC
24.Disposable Perfusion SetsHeat and moisture exchange/filterIt is intended to use for airway management by anaesthesia/respiratory care department.B
25.CathetersBalloon dilators for GastroenterologyUsed to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.C
26.Internal Prosthetic ReplacementsHernia meshIndicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.C
27.Disposable Hypodermic NeedlesDental needlesDental needles are used to deliver local anaesthetic to the operative site in order to make a patient as comfortable as possible.B
28.Disposable Hypodermic NeedlesSpinal NeedlesUsed for diagnostic sampling of cerebrospinal fluid, delivering anesthetics and for the introduction of contrast mediumB
29.Disposable Hypodermic SyringesOphthalmic Viscosurgical DeviceViscoelastic solution for Intraocular use during eye surgery.C
30.CathetersNegative pressure wound therapy bandageIntended to generate negative pressure or suction to remove wound exudates , infection materials and tissue debris from the wound bed which may promote wound healing.C
31.Ablation DevicesNeedle ElectrodeThe needle electrode family is intended to be used in conjunction with the RF generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.C
32.Ablation DevicesRadio Frequency (RF) GeneratorIntended for general use in electrosurgical coagulation of tissue.C
33.Surgical dressingsAbsorbent Cotton woolIt is intended to used for applying medication to, or absorbing small amounts of body fluidsA

 

Notice

File No. 29/Misc/3/2018-DC(85) Date: 06.06.2018

In continuation to the earlier Notice vide File No: 29/Misc./3/2017-DC(292) dated 01.11.2017 regarding Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, the Annexure-1 is hereby revised for the following changes:

 

  1. Deletion of S.N. 333 i.e. Sterile
  2. Revision of risk class of following products:

 

S.N.Product NameEarlier Risk

Classification

Revised Risk Classification
256Intra Osseous Fixation WireClass BClass C
259Bone WireClass BClass C
260Bone CapClass BClass C
321Plates, Clippers,

Screws

Class BClass C

 

***

 

Annexure 1 (Amended as on 06.06.2018)

LIST OF MEDICAL DEVICES AND IN VITRO DIAGNOSTICS ALONG WITH THEIR RISK CLASS AS PER THE PROVISIONS OF RULE 4 OF THE MEDICAL DEVICES RULES 2017

#Notified Device
Category/Drug
Device NameRisk ClassGeneral Intended Use
1Ablation DeviceVein Ablation DeviceClass CIt is a non-thermal, minimally-invasive Choice for treating the source of varicose veins, providing patients with immediate recovery and a return to normal daily routines
2Ablation DeviceThermal Ablation DeviceClass CDestruction of tissue by application of heat. Ablation of the endometrium as a treatment for menorrhagia is performed by placing a balloon filled with hot water in the uterine cavity.
3Ablation DeviceRadiofrequency Ablation DeviceClass DA medical procedure in which part of the electrical conduction system of the heart, tumour or other dysfunctional tissue is ablated using the heat generated from high frequency alternating current
4Ablation DevicePercutaneous Conduction Tissue AblationClass DClinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated.
5Ablation DeviceSuction Ablation Catheter SystemClass DIntended for use in inactivating portions of the heart’s conduction system to prevent abnormal heartbeat rates, comprises a tubular body having an open, distal end and a proximal aperture for applying suction through the catheter and through the distal end.
6Ablation DeviceUterine balloon therapy devicesClass CSystem is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
7Ablation DeviceRF Conducte MR steerable electrode catheterClass CIt is intended for intracardiac ablation.
8Bone CementsBone cementClass CIntended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
9Cardiac StentsCoronary stentClass DA coronary stent is a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease.
10Cardiac StentsBioresorbable Vascular Scaffold (BVS) SystemClass DAn absorbable stent which is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open.
11Cardiac StentsBifurcation StentClass CIntended for improving the side branch luminal diameter of arterial bifurcation liaisons.
12CathetersFiberoptic Oximeter CatheterClass BIntended for monitoring the balance between oxygen delivery and consumption at the bedside
13CathetersA-V Shunt or Fistula AdapterClass BA blood access device and accessories is a device intended to provide access to a patient’s blood for haemodialysis or other chronic uses.
15CathetersTranscervical(Ami noscope)
Endoscope and accessories
Class BIt is a device designed to permit direct viewing of the foetus and amniotic sac by means of an open tube introduced into the uterus through the cervix.
16CathetersForceps, endoscopicClass BGrasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
17CathetersTransabdominal (Fetoscope) Aminoscope and AccessoriesClass CIt is a device designed to permit direct visual examination of the foetus by a telescopic system via abdominal entry. The device is used to ascertain foetal abnormalities
18CathetersAnaesthetic Conduction KitClass CAn anaesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anaesthesia. The device may contain syringes, needles, and drugs.
19CathetersAngiographic Guide WireClass DIt delivers radio opaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
20CathetersCardiac Catherization KitClass DCardiac catheterization is a general term for a group of procedures that are performed using this method, such as coronary angiography and left ventricle angiography
21CathetersVena Cava Filter SetsClass CIt is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava to treat various disease conditions.
22CathetersVessel Dialator for percutaneous CatheterizationClass BA vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
23CathetersTracheobronchial Suction CatheterClass BClearing the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.
24CathetersCervical DrainClass BThe device is used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re- intubation, delayed extubation, or respiratory distress
25CathetersRectal BalloonClass BReducing the intrafraction motion and improving the sparing of rectal wall by reducing the rectal volume in the high- dose region, resulting in significant reduction in rectal toxicity.
26CathetersBalloon for Cerebrovascular OcclusionClass DBalloon used to treat Blockage or closing of Cerebrovascular vessels/carotid arteries
27CathetersIntra-Aortic System Balloon and ControlClass DIt is a mechanical device that increases myocardial oxygen perfusion while at the same time increasing cardiac output
28CathetersBiliary Stone Retrieval BasketClass BIntend to extract stones in an antegrade fashion through an ampullary orifice previously treated by endoscopic sphincterotomy or less commonly with balloon dilation
29CathetersTracheostomy Tube/Tracheal TubeClass BA breathing tube inserted into a tracheotomyused to obtain a closed circuit for ventilation
30CathetersVial AdapterClass BIt is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
31CathetersSuprapubic, non- disposable CannulaClass BAn emergency measure for the relief of acute urinary retention or condition which require temporary and permanent drainage of bladder.
32CathetersNasopharyngeal Catheter/Nasophar yngealClass AA catheter (for adults) passed through the nares and advanced to the depth of the nasopharynx to remove air choke or obstruction. AResuscitator.
33CathetersEsophageal obturatorClass BInserted through a patient’s mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea.
34CathetersBalloon Catheter for Retinal ReattachmentClass BAn instrument for reattachment of a detached retina to the inner wall of the eyeball. It can be inserted into the interior of the eyeball.
35CathetersGastric, Colonic, etc.) Irrigation and Aspiration CatheterClass BUsed for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
36CathetersSuction Tip and CatheterClass BSuction Catheters feature a whistle tip and a thumb control port for precise and accurate suctioning.
37CathetersAngiographic CatheterClass BDesigned to provide a pathway for delivering contrast media to selected sites in the device vascular system including the carotid arteries.
38CathetersArterial CatheterClass BIntended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature.
39CathetersBalloon Type CatheterClass B„Soft“ catheter with an inflatable „balloon“ at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body.
40CathetersBalloon Dialation Vessel CatheterClass BIntended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
41CathetersBartholin Gland CatheterClass BCatheter is used for the treatmenti of abscesses and cysts of the Hartholin gland.
42CathetersBronchography CatheterClass BIntended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or
43CathetersCholangiography CatheterClass BDiagnostic evaluation of the bile ducts during laparoscopic cholecystectomy procedures
44CathetersAnesthetic Conduction CatheterClass BAn anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia
45CathetersAnesthesia conduction filterClass CA microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid
46CathetersContinuous Flush CatheterClass BIntended for the controlled and selective infusion of
47CathetersContinuous Irrigation CatheterClass BIntended to be used to introduce fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
48CathetersCoude CathetersClass BIt is a urinary catheter, It may be used to inject liquids used for treatment or diagnosis of bladder conditions.
49CathetersDepezzer CatheterClass BA tubular, flexible instrument, passed through body channels for withdrawal o f fluids from a body cavity.
50CathetersDouble lumen Female Urethrographic CatheterClass BIntended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drag infusion.
51CathetersEpidural CatheterClass BEpidural catheter is a very thin, flexible tube that is implanted into spine
52CathetersEsophageal Balloon CatheterClass Bintended for use in adult and adolescent populations
53CathetersEustachian CatheterClass BIt is used to test Eustachian tube patency
54CathetersGuiding CatheterClass BThe guide catheter provides support for device advancement .
55CathetersHaemodialysis CatheterClass BA catheter used for exchanging blood to and from the haemodialysis machine from the patient.
56CathetersCentral Venous CathetersClass CIt is indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
57CathetersIntramuscular Pressure Monitoring CatheterClass BA modified fibre optic transducer- tipped catheter system for measuring intramuscular pressures during exercise was determined.
58CathetersIntroducer SheathClass CIntended to provide easier access to the femoral, popliteal and infrapopliteal arteries.
59CathetersIntravenous CatheterClass BA catheter that is inserted into a vein for supplying medications or nutrients dir ectly into the bloodstream or for diagno sticpurposes such as studying blood pressure
60CathetersJejunostomy CatheterClass BUsed for intraoperative feeding jejunostomy
61CathetersMultiple Lumen CatheterClass BIntended for monitoring central venous pressure (CVP), sampling blood, and simultaneou administratio of multiple IV solutions or drugs
62CathetersNasal Oxygen CatheterClass BIt is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
63CathetersEmbolic Filter systemClass DIt is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
64CathetersCarotid Filter SystemClass CUsed while performing angioplasty and stenting procedures in carotid arteries.
65CathetersRETRIEVAL SNAREClass Cintended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra- cranial neurovascular anatomy.
66CathetersRETRIEVAL SNAREClass Dintended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral system and the extra cranial neurovascular anatomy.
67CathetersNephrostomy CatheterClass BA nephrostomy is a tube that’s used to drain urine from a kidney into a bag outside the body.
68CathetersPeritoneal Dialysis CatheterClass BThat allows dialysis fluid to enter the abdominal cavity, dwell inside for a while, and then drain back out again
69CathetersRadiographic (Non Vascular) CatheterClass BInterventional radiologists obtain images using needles and narrow tubes called catheters, rather than by making large incisions into the body as in traditional surgery.
70CathetersRectal CatheterClass BIt is inserted into the rectum in order to relieve flatulence which has been chronic and which has not been alleviated by other methods.
71CathetersRetention Type CatheterClass BThis type of catheter is placed into the bladder and secured there for a period of time.
72CathetersRetention Type Balloon CatheterClass BIt has a balloon at the distal end, which is inflated with sterile water or saline to prevent the catheter from slipping out of the bladder
73CathetersSalpngography CatheterClass BUsed for injection of contrast medium
into the fallopian tube(s) for selective salpingography.
74CathetersSingle Needle Hemodialysis Catheter/Blood linesClass BThe single-needle dialysis, in which case only one cannula or a single- lumen catheter is used to access the blood
75CathetersStraight CatheterClass BIt is used in patients with neurogenic bladder or spinal cord injury, lessens the risk of urinary tract infection
76CathetersSubclavian CatheterClass BCatheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or auxiliary vein),
77CathetersSuprapubic CatheterClass BA suprapubic catheter is a thin, sterile tube used to drain urine from bladder.
78CathetersUmblical Artery CatheterClass BUmbilical artery catheterization provides direct access to the arterial blood supply and allows accurate measurement of arterial blood pressure, a source of arterial blood sampling, and intravascular access for fluids and medications
79CathetersUpper Urinary Tract CatheterClass BThe catheter to the bladder and subsequently to the upper urinary tract
80CathetersUrethral Catheter/Nelaton Catheter/ Foley CatheterClass BA long, small gauge catheter designed f or insertion directly into a ureter, either through the urethra andbladder or post eriorly via the kidney.
81CathetersUrethrographic Male CatheterClass BA catheter used to pass into a man’s bladder.
82CathetersChorionic Villus Sampling CatheterClass BAn ultrasound guides a thin catheter through the cervix to your placenta. The chorionic villi cells are gently suctioned into the catheter.
83CathetersSclerotherapy Needle/ CatheterClass BSclerotherapy Needles are designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic mucosal resection (EMR)
84CathetersWater Jet Renal CatheterClass BA device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit.
85CathetersHemodialysis Catheter (Long Term )Class CA dialysis catheter is a catheter used for exchanging blood to and from the hemodialysis machine from the patient. The dialysis catheter contains two lumens: Venous. Arterial
86CathetersPercuataneous Intravascular Long Term CatheterClass CThe device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood;
87CathetersPercutaneous Long Term Intraspinal CatheterClass CTo conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump
88CathetersImplanted Subcutaneous Intravascular Port & CatheterClass CThe device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood
89CathetersSubcutaneous Intraspinal Port & CatheterClass CCatheters used for both epidural Intrathecal infusion include short-term externalized catheters and long-term catheters that are tunnelled in the subcutaneous tissue
90CathetersPeripheral, Transluminal Angioplasty CatheterClass CA catheter for treating peripheral vascular diseases
91CathetersCardiac Thermodilution CatheterClass DA catheter used in thermodilution for in troduction of the cold liquid indicator into thecardiovascular system or for the assessment of a patient’s hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions.
92CathetersCardiovascular CatheterClass DA thin, hollow tube called a catheter is inserted into a large blood vessel that leads to heart.
93CathetersCerebrospinal CatheterClass DFor treatment or prevention of cranial/spinal cerebrospinal fluid fistula.
94CathetersAtherectomy Coronary CatheterClass DA catheter containing a rotating cutter and a collecting chamber for debris, used for atherectomy and endarterectomy.
95CathetersElectrode Recording Probe, Electrode Recording CatheterClass DA cardiac catheter containing one or more electrodes; it may be used to pace the heart or to deliver high energy shocks.
96CathetersOximetry catheters, Oximetry Paceport catheterClass BIt is indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions
97CathetersEmbolectomy CatheterClass Dindicated for the removal of fresh, soft emboli and
98CathetersFlow Directed CatheterClass BUsed for venous sampling and pressure monitoring.
99CathetersUltrasonic maging CatheterClass Dintended for ultrasound examination of peripheral pathology only
100CathetersIntraaortic Balloon CatheterClass DIt is indicated for use in patients undergoing cardiopulmonary bypass.
101CathetersIntracardiac Mapping, High Density Array CatheterClass DA high density array catheter once used in the right atrium to map and diagnosis complexarrhythmias and assess the effe ctiveness of ablation treatment.
102CathetersCoronary Dilation CatheterClass CIt is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
103CathetersIntravascular Occluding CatheterClass DIt is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms of intracranial blood vessels
104CathetersIntravascular Diagnostic CatheterClass DUsed to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
105CathetersOcclusion CatheterClass DInsertion of a device or develop at any time during the course of intravenous (IV) therapy.
106CathetersPercutaneous CatheterClass DA needle catheter getting access to a blood vessel, followed by the introduction of a wire through the lumen (pathway) of the needle.
107CathetersDiagnostic Radiology CathetersClass CAngiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
108CathetersPerfusion CatheterClass DPerfusion catheter allowing localised perfusion of drugs not only into the vessel lumen, but also directly into the vessel wall at low pressure, during coronary intervention. –
109CathetersPericardium Drainage CatheterClass DCatheter drainage of the pericardium
110CathetersAtherectomy Peripheral Catheter
Class D
Intended for use in atherectomy of the peripheral vasculature.
111CathetersSeptostomy CatheterClass DUsed to enlarge interatrial openings
112CathetersThrombectomy CatheterClass DThrombectomy catheter is specifically designed to treat deep vein thrombosis (DVT) in large-diameter upper and lower peripheral veins.
113CathetersTransluminal, Coronary Angioplasty, Percutaneous CatheterClass DThe catheter is placed in the opening or ostium of one the coronary arteries
114CathetersVentrricular CatheterClass CIt is used to monitor pressure in patients with brain injuries, intracranial bleeds or other brain abnormalities that lead to increased fluid build-up.
115CathetersBalloon Repair Kit CatheterClass CA device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to affect the repair or replacement.
116CathetersMicro-catheterClass CIt is intended to access the peripheral and neurovasculature for the controlled selective infusion of physician- specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media
117CathetersImaging CatheterClass CIntended for use with the various medical imaging consoles.
118CathetersCentral Nervous System Shunt including Neurological catheters and other ComponentsClass DIt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume.
119CathetersEndoscopic Ligation DevicesClass BIt is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
120CathetersDialysate Tubing and ConnectorClass BA tubing connector adapted for peritoneal dialysis connections between tubing sets and containers of dialysate
121
Catheters
Urinary Drainage UnitClass BA closed urinary drainage system consists of a catheter inserted into the urinary bladder and connected via tubing to a drainage bag
122CathetersTympanostomy TubeClass CIt is a small tube inserted into the eardrum in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear
123CathetersIn-Vitro Fertilization/Embryo Transfer CatheterClass BA cellular transfer catheter is provided for implantation of cellular material into the uterus of a patient
124CathetersSclerotherapy Needle/ CatheterClass BIt is designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic
125CathetersFluid Delivery tubingClass BTube used to deliver fluid in body
126CathetersColon TubeClass BColon Tubes also called „Tips“ or even Catheters are inserted from the anus, through the rectum to deliver your enema solution into the colon (large intestine).
127CathetersConnecting TubeClass BUsed to provide connection to a drainage bag.
128CathetersDecompression TubeClass BDecompression using a rectal tube may assist in the treatment only if the sigmoid colon is involved.
129CathetersDouble Lumen for intestinal Decompression and/or Intubation TubeClass BTracheal intubation, usually simply referred to as intubation, is the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway or to serve as a conduit through which to administer certain drugs.
130CathetersClosed Wound Drainage Tube or SystemClass BA surgical drain is a tube used to remove pus, blood or other fluids from a wound. They are commonly placed by surgeons or interventional radiologists.
131CathetersOesophageal Blakemore TubeClass BIt is a medical device inserted through the nose or mouth and used occasionally in the management of upper gastrointestinal hemorrhage due to oesophageal varices .
132CathetersOesophageal Sengtaken TubeClass BIt is used only in emergencies where bleeding from presumed varices is impossible to control with medication alone
133CathetersFeeding TubeClass BA feeding tube is a device that’s inserted into your stomach through your abdomen. It’s used to supply nutrition when you have trouble eating
134CathetersGastro- Enterostomy TubeClass BTube is placed through the abdominal wall into the stomach and then through the duodenum into the jejunum.
135CathetersGastrointestinal TubeClass BA gastrostomy tube (also called a G- tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach
136CathetersHeart-Lung Bypass Unit TubeClass BA tube will be placed in your heart to drain blood to the machine.
137CathetersLevine TubeClass BUsed for the aspiration of gastric and intestinal contents and administration of tube feedings or medications.
138CathetersNasoGastric Tube/ Ryles TubeClass BIt is a special tube that carries food and medicine to the stomach through the nose. It can be used for all feedings or for giving a person extra calories.
139CathetersNephrostomy TubeClass BThe nephrostomy tube drains urine from kidney into a collecting bag outside the body.
140CathetersOrthodontic TubeClass BAn orthodontic small metal part welded on the outside of a molar bank, which contains slots to holdarchwires, lip bu mpers, facebows and other devices use d to move the teeth.
141CathetersRectal TubeClass BA rectal tube, also called a rectal catheter, is a long slender tube which is inserted into the rectum in order to relieve flatulence .
142CathetersStomach Evaculator(Gastric Lavage) TubeClass BPassage of a tube via the mouth or nose down into the stomach followed by sequential administration and removal of small volumes of liquid.
143CathetersTonsil Suction TubeClass BUsed to suck out stones in tonsils.
144CathetersTracheal (Endotracheal) TubeClass BInserts the tube with the help of a laryngoscope, an instrument that permits to see the upper portion of the trachea, just below the vocal cords.
145CathetersClosed Suction SystemClass BIt is intended for endotracheal suctioning to provide a patient airway by removing excess fluids, secretions, exudates and transudate through the artificial airway.
146CathetersAnastomosis Bypass TubeClass CIt is anchored to mucosa and submucosa 3 centimetres proximal to a site of colocolonic anastomosis and later spontaneously evacuated by way of the rectum.
147CathetersEndolymphatic Shunt TubeClass BDuring a surgical procedure in which it is placed in the membranous labyrinth of the inner ear to drain excess fluid.
148CathetersOrthodontic Guide WireClass BA wire conforming to the alveolar or dental arch that can be used with dental braces as a source of force in correcting irregularities in the position of the teeth
149CathetersIntra-aortic balloon and control systemClass DIt is a medical device which is placed in the aorta to improve cardiovascular functioningduringcertain life- threatening emergencies.
150CathetersVentricular bypass (assistive)Class DA ventricular bypass (assistive) device is a device that assists the left or right ventricle in maintaining circulatory blood flow.
151CathetersCatheter Guide WireClass DIt is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The PTCA Guide Wires are not to be used in the cerebral blood vessel
152CathetersCatheter GuideClass DIt is intended to facilitate the placement of balloon ilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). PTCA Guide Wires are not to be used in the cerebral blood vessel.
153CathetersWireClass CAn esophageal stent is a stent (tube) placed in the oesophagus to keep a blocked area open so the patient can swallow soft food and liquids
154CathetersBiliary stentsClass CBiliary stents provide bile drainage from the gallbladder, pancreas and bile ducts to the duodenum in conditions such as ascending cholangitis due to obstructing gallstones
155CathetersDuodenal stentsClass CDuodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions
156CathetersColonic stentClass CA colonic stent is a flexible, hollow tube designed to keep a segment of the colon (large bowel) open when it has become blocked(obstructed). This blockage is commonly caused by a tumour inside the bowel or by outside pressure on the bowel wall.
157CathetersPancreatic stentClass CPancreatic duct stents are often placed in patients who have chronic pancreatitis
158CathetersCarotid Stent SystemClass DIndicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
159CathetersPeripheral Stent SystemClass CA Peripheral stent is a tube-shaped device placed in the peripheralarteries that supply blood into body organ.
160ContraceptivesTubal Rings/ Fallopian RingsClass CContraception devices for female sterilization
161ContraceptivesMale / Female CondomsClass CCondom with nonoxynol-9, micro condom, prophylactic (condom) – latex sheath, non-latex, condoms with natural membrane, intra vaginal condoms etc.
162ContraceptivesCu-TClass DIndicated for intrauterine contraception for up to 10 years.
163DisinfectantsDisinfectantsClass BAn agent that destroys pathogenic and other kinds of microorganisms by chemical or physical means. A disinfectant destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores. It is intended to disinfect a medical device.
164Disposable Hypodermic NeeldesAspiration NeedleClass BUsed for either laparoscopic aspiration or injection
165Disposable Hypodermic NeeldesAspiration and Injection NeedleClass BA thin needle is inserted into an area of abnormal-appearing tissue or body fluid. As with other types of biopsies, the sample collected during fine needle aspiration can help make a diagnosis or rule out conditions such as cancer.
166Disposable Hypodermic NeeldesInsulin Needles/PenClass BUsed to inject insulin for the treatment of diabetes.
167Disposable Hypodermic NeeldesNeedles for insulin Medication InjectorClass BA subcutaneous injection is a method of administering medication.
168Disposable Hypodermic NeeldesBiopsy Needle KitClass BA set of neurosurgical instruments designed to allow multiple biopsies from one or more targets in one trajectory
169Disposable Hypodermic NeeldesAngiographic NeedleClass BAngiographic needle has a unique hub design with an ergonomic feel and a black triangle indicator to orient the bevel.
170Disposable Hypodermic NeeldesMammary Biopsy NeedleClass BThe growth sample is suctioned out through a needle or cut out using a surgical procedure
171Disposable Hypodermic NeeldesBlood Collecting NeedleClass BIntended to be used with evacuated blood collection tube for collection of venous blood.
172Disposable Hypodermic NeeldesBone Marrow NeedleClass BNeedle inserted in Bone Marrow to collect sample
173Disposable Hypodermic NeeldesGynaecological Cerclage NeedleClass BIt is a loop like instrument used to suture the cervix.
174Disposable Hypodermic NeeldesCholangiography NeedleClass BThe aspirating needle is passed through the patient’s skin and liver tissue until the tippenetrates one of the hepatic ducts
175Disposable Hypodermic NeeldesAnaesthetic Conduction NeedleClass BAn anaesthesia conduction needle is a device used to inject local anaesthetics into a patient to provide regional anaesthesia
176Disposable Hypodermic NeeldesEmergency Airway NeedleClass BEmergency airway puncture is the placement of a hollow needle through the throat into the airway. It is done to treat life-threatening choking.
177Disposable Hypodermic NeeldesEndoscopic NeedleClass BUsed to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
178Disposable Hypodermic NeeldesFistula NeedleClass BTo connect blood lines with the blood vessels through needles when dialysis is carried out
179Disposable Hypodermic NeeldesEpidural NeedleClass BIntended for transient delivery of anasthetics to provide regional anesthesia or to facilitate placement of an epidural catheter
180Disposable Hypodermic NeeldesGastro-Urology NeedleClass BIntended for gastroenterology biopsy
181Disposable Hypodermic NeeldesSingle Lumen Hypodermic NeedleClass BA hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
182Disposable Hypodermic NeeldesNeurosurgical Suture NeedleClass BA needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
183Disposable Hypodermic NeeldesOocyte Aspiration NeedleClass BMission to collect the maximum amount of undamaged oocytes in a short time as possible.
184Disposable Hypodermic NeeldesPneumoperitoneu m Simple NeedleClass BInserting a Veress needle through the abdominal wall inside the peritoneal cavity.
185Disposable Hypodermic NeeldesPrefillable Glass Barrel with needleClass BIntended for the automatic self- administration of drugs and biologics from standard Glass Barrel.
186Disposable Hypodermic SyringesInjector Type actuator syringeClass CA syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.
187Disposable Hypodermic SyringesAspiration SyringeClass BUsed for either laparoscopic aspiration or injection
188Disposable Hypodermic SyringesIrrigating SyringesClass Bcleaning debris away from the area the dentist is working on
189Disposable Hypodermic SyringesInsulin SyringesClass BUsed to inject insulin for the treatment of diabetes.
190Disposable Hypodermic SyringesAuto Disable Syringe for single useClass BIntend to inject fluids into or withdraw fluids from the body.
191Disposable Hypodermic SyringesTraditional single use syringe without safety feature (Sterile hypodermic syringes for single use)Class BIntend to inject fluids into or withdraw fluids from the body.
192Disposable Hypodermic SyringesAuto-disable (AD) syringes for immunizationClass BIntend to inject fluids into or withdraw fluids from the body.
193Disposable Hypodermic SyringesRe use Prevention (RUP) syringes for therapeutic injectionsClass BIntend to inject fluids into or withdraw fluids from the body.
194Disposable Perfusion Sets(Syringes with re-use prevention feature) Sharps Injury Protection (SIP) – Plastic needle shield to be added to a syringeClass BIntend to inject fluids into or withdraw fluids from the body.
195Disposable Perfusion SetsSharps Injury Blood Administration kitsClass BIt is used to administer blood from a container to a patient’s vascular system through a needle or catheter inserted into a vein.
196Disposable Perfusion SetsMeasured Volume IV SetClass BIt is intended for use in the administration of fluids from a container into the patient’s vascular system through a vascular access device.
197Disposable Perfusion SetsTransfusion or Perfusion sets for single useClass BTransfusion Set is used to administer blood/drugs to a patient’s vascular system through a needle or catheter inserted into a vein.
198Disposable Perfusion SetsCustom Perfusion SystemClass CIndicated for use in the extra corporeal circuit during cardio pulmonary bypass surgery procedure.
199Disposable Perfusion SetsManifoldsClass BIndicated for fluid flow directional control and for providing access port/ports for administration of a solution.
200Disposable Perfusion Sets3 way stop cock as an accessory to perfusion setsClass BIt is indicated for fluid flow directional control and for providing access port for administration of solution, withdrawal of fluid and pressure monitoring
201Disposable Perfusion SetsY-Connector as an accessory to perfusion setsClass AIt can be used to connect to a perfusion sets or catheter for infusion of contrast media etc.
202Disposable Perfusion SetsI V Flow regulatorClass BAn IV system and administration device offering precision care and consistent delivery.
203Disposable Perfusion SetsExtension SetsClass BExtension sets are sterile devices for single use only. They are intended to be used as part of a system for the infusion of fluids/medications in medical applications.
204Disposable Perfusion SetsInfusion Pump or Elastomeric Infusion DeviceClass CThe Infusion Pumps intended for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously
for post operative pain management.
205Drug Eluting StentsDrug eluting stentClass DStent, coronary, drug-eluting – a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
206Heart ValvesHeart valveClass DA device intended to perform the function of any of the heart’s natural valves.
207Internal Prosthetic ReplacementsTissue ExpandersClass CIntended to be used in breast reconstruction or treatment of soft tissue deformities such as used following mastectomy or for treatment of underdeveloped breasts.
208Internal Prosthetic ReplacementsBio PatchesClass CIntended for reconstruction and repair of defects of pericardium.
209Internal Prosthetic ReplacementsVascular graft/occluders/Car diac PatchesClass DIntended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
210Internal Prosthetic ReplacementsVascular embolization deviceClass DIt is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors.
211Internal Prosthetic ReplacementsVoice / laryngeal ProthesisClass CThe device is intended to direct pulmonary air flow to the pharynx in the absence of the larynx, for permitting esophageal speech.
212Internal Prosthetic ReplacementsCardiovascular prosthetic devicesClass DAn intra-cardiac patch or pledgete which is a medical device placed in the heart and is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
213Internal Prosthetic ReplacementsHearing Prosthesis SystemClass CThe prostheses are intended for partial ossicular replacement to restore functionality to the middle ear .
214Internal Prosthetic ReplacementsAnnuloplasty ringClass CAn annuloplasty ring implanted around the mitral or tricuspid heart valve for reconstructive treatment.
215Internal Prosthetic ReplacementsTotal ossicular replacement prosthesisClass DIt is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.
216Internal Prosthetic ReplacementsEar, nose, and throat and facial synthetic polymer material or implantClass CIt is a device material that is intended to be implanted for use as a space- occupying substance in the reconstructive surgery of the head and neck.
217Internal Prosthetic ReplacementsMandibular implant facial prosthesisClass CIntended to be implanted for use in the functional reconstruction of mandibular deficits.
218Internal Prosthetic ReplacementsSacculotomy tack (Cody tack)Class CIntended to be implanted to relieve the symptoms of vertigo.
219Internal Prosthetic ReplacementsEndolymphatic shuntClass CIntended to be implanted to relieve the symptoms of vertigo.
220Internal Prosthetic ReplacementsAn endolymphatic shunt tube with valveClass CIt is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss.
221Internal Prosthetic ReplacementsFallopian tube prosthesisClass CA device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.
222Internal Prosthetic ReplacementsVaginal stentClass CA device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.
223Internal Prosthetic ReplacementsEye sphere implantClass DAn eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
224Internal Prosthetic ReplacementsKeratoprosthesisClass DIt is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye.
225Internal Prosthetic ReplacementsBone heterograftClass DIntended to be implanted that is made from bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
226Internal Prosthetic ReplacementsIntramedullary fixation rodClass CIntended to be implanted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
227Internal Prosthetic ReplacementsEndosseous dental implantClass CIntended to be surgically placed in the bone of jaw arches to provide support for prosthetic devices, such as artificial teeth.
228Internal Prosthetic ReplacementsDental implantClass CA dental implant is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor.
229Internal Prosthetic ReplacementsBone grafting materialClass CIntended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
230Internal Prosthetic ReplacementsTotal temporomandibula r joint prosthesisClass DIntended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.
231Internal Prosthetic ReplacementsGlenoid fossa prosthesisClass DIntended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
232Internal Prosthetic ReplacementsMandibular condyle prosthesisClass DIntended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.
233Internal Prosthetic ReplacementsAn interarticular disc prosthesisClass DIntended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.
234Internal Prosthetic ReplacementsPenile inflatable implantClass DA penile inflatable implant is a device which is implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. This device is used in the treatment of erectile impotence.
235Internal Prosthetic ReplacementsPenile rigidity implantClass CA device that is implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction
236Internal Prosthetic ReplacementsArtificial Urinary Sphincters implantsClass CIt is used to prevent incontinence by occluding the urethra.
237Internal Prosthetic ReplacementsImplanted mechanical/hydrau lic urinary continence deviceClass CAn implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra.
238Internal Prosthetic ReplacementsCochlear implantClass DA cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.
239Internal Prosthetic ReplacementsRetinal implantClass DThe retinal implant is meant to partially restore useful vision to people who have lost their vision due to degenerative eye conditions
240Internal Prosthetic ReplacementsBreast implantClass CBreast implant is used to increase the breast size.
241Internal Prosthetic ReplacementsTracheal prosthesiClass CIt is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree
242Internal Prosthetic ReplacementsPolymeric Surgical MeshClass CThe polymeric mesh comprises an absorbable polymeric fibre and a non- absorbable polymeric fibre knitted together to form an interdependent, co-knit mesh structure
243Internal Prosthetic ReplacementsEndosseousClass CIntended for use as an aid in prosthetic rehabilitation.
244Internal Prosthetic ReplacementsA testicular prosthesisClass DA testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.
245Internal Prosthetic ReplacementsAneurysm Implant (detachable coils/clips)Class DIt is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
246Intra Ocular LensesIntraocular lensClass CIntraocular lens (IOL) are lens implanted in the eye used to treat cataracts or myopia
247IV CannulaeIntravenous CannulaClass BThe IV Cannula is a passive device to provide for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices .
248IV CannulaeArterial CannulaClass BInserted into an artery, commonly the radial artery, and is used during major operations and in critical care areas to measure beat-to-beat blood pressure and to draw repeated blood samples.
249IV CannulaeCoronary Artery CannulaClass BCannulation technique for left-sided coronary artery surgery.
250IV CannulaeHemodialysis CannulaClass BAllowing the arterial blood to flow to the dialyzer and the dialyzed blood to return from the dialyzer to the circulation through the cannula in the vein.
251IV CannulaeVena Cava CannulaClass BInserted into Vena Cava, taking deoxygenated blood to heart.
252IV CannulaeVenous CannulaClass BIt is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
253IV CannulaeVentricular CannulaClass BFor use in neurosurgical procedures. It is specially designed to penetrate delicate brain tissue and give continued access to brain’s ventricular system.
254IV CannulaeA-V Shunt CannulaClass CIt is inserted into one of the client’s blood vessels to facilitator repeated hemodialysis.
255IV CannulaeCannulact or Lymph DuctClass BA lymph duct is a great lymphatic vessel that empties lymph into one of the subclavian veins
256Orthopaedic ImplantsIntra Osseous Fixation WireClass CStabilization of fractured bony parts by direct fixation to one another with surgical wires
257Orthopaedic ImplantsCortical Fixation Implant / rigidloop Adjustable Cortical Fixation SystemClass CCortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments.
258Orthopaedic ImplantsIntervertebral Body Fusion Device / Fuse Spinal SystemClass CIt is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease („DDD“) at one or two contiguous spinal levels.
259Orthopaedic ImplantsBone WireClass CIntended to be used for bone stabilization in the hand and wrist.
260Orthopaedic ImplantsBone capClass CIntended to be implanted to cover the end of a bone.
261Orthopaedic ImplantsOrthopedic implant & accessoriesClass CIntended to replace a missing joint or bone or to support a damaged bone.
262Orthopaedic ImplantsIntervertebral body fusion deviceClass DThe device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion
263Orthopaedic ImplantsPedicle screw spinal systemClass CIt is used to intended to provide immobilization and stabilization of spinal segments
264Orthopaedic ImplantsAnkle joint metal/composite semi-constrained
cemented
prosthesis
Class CAn ankle joint metal/composite semi- constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint.
265Orthopaedic ImplantsAnkle joint metal/polymer non-constrained cemented prosthesisClass CA device intended to be implanted to replace an ankle joint. The device limits minimally translation in one or more planes. It has no linkage across- the-joint.
266Orthopaedic ImplantsElbow joint metal/polymer constrained cemented prosthesisClass CAn elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint.
267Orthopaedic ImplantsElbow joint metal/polymer semi-constrained cemented prosthesisClass CAn elbow joint metal/polymer semi- constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint
268Orthopaedic Implantselbow joint radial (hemi-elbow) polymerClass CAn elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
269Orthopaedic ImplantsElbow joint humeral (hemi- elbow) metallic uncemented prosthesisClass CA device intended to be implanted made of alloys, such as cobalt- chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulumhumeri
270Orthopaedic Implantselbow joint humeral (hemi- elbow) metallic uncemented prosthesis
Class C
A device intended to be implanted made of alloys, such as cobalt- chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulumhumeri
271Orthopaedic ImplantsFinger joint metal/metal constrained uncemented prosthesisClass CA device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
272Orthopaedic ImplantsFinger joint metal/metal constrained cemented prosthesisClass CA finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint
273Orthopaedic ImplantsFinger joint polymer constrained prosthesisClass CA device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
274Orthopaedic Implantship joint metal constrained cemented or uncemented prosthesisClass DA hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
275Orthopaedic ImplantsHip joint metal/polymer constrained cemented or uncemented prosthesisClass DA hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
276Orthopaedic ImplantsHip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.Class DIt is a prosthesis intended to be implanted to replace a hip joint
277Orthopaedic Implantship joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesisClass DIntended to be implanted to replace a hip joint
278Orthopaedic Implantship joint metal/composite semi-constrained cemented prosthesisClass CA hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip joint
279Orthopaedic ImplantsHip joint metal/ceramic/poly mer semi-constrained cemented or nonporous uncemented prosthesisClass CIntended to be implanted to replace a hip joint
280Orthopaedic ImplantsHip joint metal/polymer/met al semi-constrained porous-coated uncemented prosthesis.Class CIntended to be implanted to replace a hip joint
281Orthopaedic ImplantsA knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee jointClass CIntended to be implanted to replace part of a knee joint
282Orthopaedic ImplantsShoulder joint metal/metal or metal/polymer constrained cemented prosthesisClass CIntended to be implanted to replace a shoulder joint
283Orthopaedic ImplantsWrist joint carpal lunate polymer prosthesisClass CIntended to be implanted to replace the carpal lunate bone of the wrist.
284Orthopaedic ImplantsWrist joint metal/polymer semi-constrained cemented prosthesisClass CIntended to be implanted to replace a wrist joint.
285Orthopaedic ImplantsWrist joint metal constrained cemented prosthesisClass CIntended to be implanted to replace a wrist joint
286Orthopaedic ImplantsWrist joint polymer constrained prosthesisClass CIntended to be implanted to replace a wrist joint
287Orthopaedic ImplantsWrist joint carpal trapezium polymer prosthesisClass CIntended to be implanted to replace the carpal trapezium bone of the wrist
288Orthopaedic ImplantsWrist joint carpal scaphoid polymer prosthesisClass CIntended to be implanted to replace the carpal scaphoid bone of the wrist.
290Orthopaedic ImplantsToe joint phalangeal (hemi-toe) polymer prosthesisClass CIntended to be implanted to replace the base of the proximal phalanx of the toe.
291Orthopaedic ImplantsToe joint polymer constrained prosthesisClass CIntended to be implanted to replace the first metatarsophalangeal (big toe) joint
292Orthopaedic ImplantsShoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis.Class CA shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis.
293Orthopaedic ImplantsShoulder joint glenoid (hemi- shoulder) metallic cemented prosthesisClass CIt is intended to be implanted to replace part of a shoulder joint
294Orthopaedic ImplantsShoulder joint metal/polymer/metal nonconstrained or semi- constrained porous-coated uncemented prosthesisClass CIt is a device intended to be implanted to replace a shoulder joint
295Orthopaedic ImplantsShoulder joint metal/polymer semi-constrained cemented prosthesisClass CIntended to be implanted to replace a shoulder joint
296Orthopaedic Implantsshoulder joint metal/polymer non-constrained cemented prosthesisClass CIntended to be implanted to replace a shoulder joint
297Orthopaedic ImplantsKnee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesisClass CIntended to be implanted to replace part of a knee joint
298Orthopaedic ImplantsKnee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesisClass CIntended to be implanted to replace the retropatellar articular surface of the patellofemoral joint
299Orthopaedic Implantsknee joint femoral (hemi-knee) metallic uncemented prosthesisClass CIntended to be implanted to replace part of a knee joint.
300Orthopaedic Implantsknee joint patellofemorotibial metal/polymerClass CIntended to be implanted to replace a knee joint
301Orthopaedic ImplantsKnee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis.Class CIntended to be implanted to replace a knee joint
302Orthopaedic ImplantsKnee joint patellofemorotibial polymer/metal/met al constrained cemented prosthesisClass CIntended to be implanted to replace a knee join
303Orthopaedic Implantsknee joint patellofemoral polymer/metal semi-constrained cemented prosthesisClass CIt is intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia
304Orthopaedic ImplantsKnee joint femorotibial (uni- compartmental) metal/polymer porous-coated uncemented prosthesisClass CIntended to be implanted to replace part of a knee joint
305Orthopaedic ImplantsKnee joint femorotibial metal/polymer semi-constrained cemented prosthesisClass CIntended to be implanted to replace part of a knee joint
306Orthopaedic ImplantsKnee joint femorotibial metal/polymer non-constrained cemented prosthesisClass CIntended to be implanted to replace part of a knee joint
307Orthopaedic ImplantsKnee joint femorotibial metal/polymer constrained cemented prosthesisClass CKnee joint femorotibial metal/polymer constrained cemented prosthesis
308Orthopaedic ImplantsKnee joint femorotibial metal/polymer constrained cemented prosthesisClass CIntended to be implanted to replace part of a knee joint.
309Orthopaedic ImplantsKnee joint femorotibial metal/composite semi-constrained cemented prosthesisClass CIntended to be implanted to replace part of a knee joint
310Orthopaedic ImplantsKnee joint femorotibial metal/composite non-constrained cemented prosthesisClass CIntended to be implanted to replace part of a knee joint
311Orthopaedic ImplantsHip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.Class CIntended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck
312Orthopaedic ImplantsHip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesisClass DIntended to be implanted to replace a hip joint
313Orthopaedic Implantship joint metal constrained cemented or uncemented prosthesisClass DIntended to be implanted to replace a hip joint
314Orthopaedic ImplantsHip joint metal/polymer constrained cemented or uncemented prosthesisClass DIntended to be implanted to replace a hip joint
315Orthopaedic ImplantsHip joint femoral (hemi-hip) metallic resurfacing prosthesisClass DIntended to be implanted to replace a hip joint
316Orthopaedic ImplantsA hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesisClass DIntended to be implanted to replace the head and neck of the femur
317Orthopaedic ImplantsA hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesisClass DIntended to be implanted to replace the head and neck of the femur
318Orthopaedic ImplantsHip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.Class DIntended to be implanted to replace the head and neck of the femur
319Orthopaedic ImplantsA hip joint (hemi-hip) acetabular metal cemented prosthesisClass DIntended to be implanted to replace a hip joint
320Orthopaedic ImplantsHip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.Class DIntended to be implanted to replace a hip joint
321Orthopaedic ImplantsPlates, clipersScrewsClass Crigid, limb brace, lumbar, lumbo- sacral, rib fracture, sacroiliac, thoracic oethosis.
322Orthopaedic ImplantsSpinal intervertebral body fixation orthosisClass CThe device is used to apply force to a series of vertebrae to correct „sway back,“ scoliosis (lateral curvature of the spine), or other conditions.
323Orthopaedic ImplantsSpinal interlaminal fixation orthosisClass CA device intended to be implanted made of an alloy, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is used primarily in the treatment of scoliosis
324Orthopaedic ImplantsResorbable calcium salt bone void filler deviceClass CA resorbable calcium saltbone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis
325Orthopaedic ImplantsSmooth or threaded metallic bone fixation fastenerClass CIt may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
326Orthopaedic ImplantsSacroiliac joint fixationClass CThe sacroiliac joints fixation may serve as protective mechanism for the lumbosacral region.
327Orthopaedic ImplantsCervical Artificial DiscClass DCervical Artificial Disc is indicated for reconstruction of the disc.
328Scalp Vein SetScalp Vein SetClass BIntended to be used for insertion into the patient’s vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
329Surgical DressingsSurgical StaplesClass BSurgical staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of body during surgery.
330Surgical DressingsSurgical DressingsClass ADressing aerosol, non-adherent, dressing, periodontal, kit, dressing pad, dressing.
331Surgical DressingsSurgical DressingsClass BDressing-gel, dressing- permeable, moisture dressing, tracheostomy tube dressing, wound and burn dressings, hydrogel dressing, wound and burn, occlusive.
332Surgical DressingsCotton GrudgesAdhesive bandages, Gauge bandages, Medical Absorbent (fiber) bandages.
333Surgical DressingsWound Dressings/Bacterio static Wound DressingsClass CIncludes Beads, Hydrophilics For Wound Exudate Absorption for wound care.
334Surgical DressingsCasting tapes/Splint RollsClass BA prosthetic and orthotic accessory, intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis.
335Surgical DressingsHaemostatic Gelatine Sponge /HaemostatClass CIntended for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
336Surgical DressingsSurgical DressingsClass CMaterial dressing, surgical, polylactic acid dressings.
337Surgical DressingsAbsorable Hemostatic BasedClass DAn absorbable haemostatic agent or dressing is a device intended to produce haemostasis by accelerating the clotting process of blood. It is absorbable.
338Surgical DressingsUmbilical occlusion deviceClass AThese devices may be a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
339Surgical DressingsBolster SutureClass ANon-latex plastic bolsters are used to hinder pressure of any temporary suture against the body during surgery.
340Surgical DressingsSuture Non Absorable SyntheticClass CNon-absorbable suture is comprised of surgical steel as well as synthetic non- absorbable sutures for use in general soft tissue approximation and ligation.
341Surgical DressingsSuture AbsorableClass CThe device is intended for use in general soft tissue approximation and ligation.
342Surgical DressingsEndovascular suturing systemClass CIt is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery.
343Surgical DressingsFixation, non- absorbable for pelvic useClass CAttaching suture or stapling ligaments of the pelvic floor.
344Surgical DressingsTissue adhesive for the topical useClass CIntended for topical closure of surgical incisions including laparoscopic incisions and simple traumatic lacerations.
345Surgical DressingsTissue adhesive for non-topical useClass DIntended for use in adhesion of internal tissues and vessels, for example; adhesives used in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery.
346Surgical DressingsAlcohol SwabsClass AIt is a single use, sterile device containing 70% Isopropyl alcohol used for scrubbing and allowing drying and will disinfect needless access sites prior to use..
347Surgical DressingsLigature WireClass Boffer a spot-welded auxiliary hook which may be added to any bracket by simply tying in the arch wire
348Surgical DressingsSurgical SealantClass BFor use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
349Surgical DressingsWound Closure DeviceClass BWound Closure Devices are indicated for soft tissue approximation.
350Surgical DressingsIntracardiac patchClass Dintracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

 

(2) rule 4 of the Medical Devices Rules, 2017

S. N.Categoryin vitro diagnostic medical deviceRisk ClassIntended use
1Clinical Chemistry Reagents/ Kits for estimation of various Parameters exemplified as:Acid Phosphatase (total or prostatic) test reagents/kitsClass BAn acid phosphatase (total or prostatic) test reagent/kit is a medical device, intended for the estimation of acid phosphatase in serum/plasma.
2Albumin test reagents/kitsClass BAn albumin test reagent/kit is a medical device intended for the estimation of albumin in serum/plasma.
3Alkaline phosphatase or isoenzymes test reagents/kitsClass BAn alkaline phosphatase or isoenzymes test reagent/kit is a medical device intended for the estimation of alkaline phosphatase or its isoenzymes in serum/plasma.
4Ammonia test reagents/kitsClass BAn ammonia test reagent/kit is a medical device intended for the estimation of ammonia levels in blood, serum/plasma.
5Amylase test reagents/kitsClass BAn amylase test reagent/kit is a medical device intended for the estimation of the enzyme amylase in serum, saliva / urine.
6Bicarbonate / carbon dioxide test reagents/kitsClass BA bicarbonate/carbon dioxide test reagent/kit s a medical device for the estimation of bicarbonate/carbon dioxide in plasma, serum/whole blood.
7bilirubin (total and direct) test reagents/kitsClass BA bilirubin (total and direct) test reagent/kit is a medical device intended for the estimation of bilirubin (total and direct) in serum/plasma.
8Calcium test reagents/kitsClass BA calcium test reagent/kit is a medical device intended for the estimation of total calcium in serum.
9Chloride test reagents/kitsClass BA chloride test reagent/kit is a medical device intended for the estimation of chloride in plasma, serum, sweat /urine.
10cholesterol (total) test reagents/kitsClass BA cholesterol (total) test reagent/kit is a medical device intended for the estimation of cholesterol in serum or plasma.
11HDL cholesterol test reagents/kitsClass BA HDL cholesterol test reagent/kit is a medical device intended for the estimation of HDL cholesterol in serum / plasma.
12LDL cholesterol test reagents/kitsClass BA LDL cholesterol test reagent/kit is a medical device intended for the estimation of LDL cholesterol in serum/plasma.
13Lipoproteinstest reagents/kitsClass BA lipoprotein test reagent/kit is a medical device intended for the estimation of lipoproteins in serum / plasma.
14Cholinesterase test reagents/kitsClass BA cholinesterase test reagent/kit is a medical device intended for the estimation of cholinesteral in serum /plasma. .
15Creatine Kinase and its isoenzymestest reagents/kitsClass BA creatine phosphokinase/creatine kinase or isoenzymes including CKMB, CKBB and CKMM test reagent/kit is a medical device intended for the estimation of the enzyme creatine phosphokinase or its isoenzymes in serum / plasma. .
16Copper test reagents/kitsClass BCopper test reagent/kit is a medical device intended for the estimation of copper in plasma, serum / urine.
17Creatinine test reagents/kitsClass BA creatinine test reagent/kit is a medical device intended for the estimation of creatinine in serum, plasma / urine.
18Gamma GlutamylTransferase (GGT) and isoenymes test reagents/kitsClass BA Gamma Glutamyl Transferase (GGT) and isoenzymes test reagent/kit is a medical device intended for the estimation of the enzyme Gamma GlutamylTransferase (GGT) in serum / plasma.
19Glucose test reagents/kitsClass BA Glucose test reagent/kit is a medical device intended for the estimation of glucose in blood/plasma/ body fluids.
20Glucose-6-Phosphate Dehydrogenase (G6PD) and its isoenzymes test reagents/kitsClass BA Glucose-6-Phosphate Dehydrogenase(G6PD)test reagents/kit is a medical device intended for the estimation of Glucose-6-Phosphate Dehydrogenase or its isoenzymes in serum / plasma. .
21Glycosylated Hemoglobin or its variants test reagents/kitsClass BGlycosylated Hemoglobin or its variants test reagents/kits are medical devices intended for the estimation of glycosylated hemoglobin or its variants including A1a, A1b, and A1c in blood.
22Hemoglobin test reagents/kitsClass BA hemoglobin test reagent/kit is a medical device intended for the estimation of hemoglobin in blood.
23Iron test reagents/kitsClass BAn iron test reagent/kit is a medical device intended for the estimation of iron in serum /plasma.
24Ferritin test reagents/kitsClass BAn Ferritin test reagent/kit is a medical device intended for the estimation of ferritin in serum / plasma
25Iron-binding capacity test reagents/kitsClass BIron-binding capacity test reagents/kits are medical devices intended for the estimation of iron- binding capacity in serum / plasma.
26Lactate Dehydrogenase and its isoenzymes test reagents/kitsClass BA Lactate Dehydrogenase and its isoenzymes test reagent/kit is a medical device intended for the estimation of enzyme Lactate Dehydrogenase and its isoenzymes in serum / plasma.
27Lipase test reagents/kitsClass BA lipase test reagent/kit is a medical device intended for the estimation of lipase in serum / plasma.
28Magnesium test reagents/kitsClass BA magnesium test reagent/kit is a medical device intended for the estimation of magnesium levels in serum / plasma.
29Phosphorus (inorganic) test reagents/kitsClass BA phosphorus (inorganic) test reagent/kit is a medical device intended for the estimation of inorganic phosphorus in serum, plasma / urine.
30Potassium test reagents/kitsClass BA potassium test reagent/kit is a medical device intended for the estimation of potassium in serum, plasma / urine.
31Aspartate Amino Transferase (AST/SGOT) test reagents/kitsClass BAn Aspartate Amino Transferase (AST/SGOT) test reagent/kit is a medical device intended for the estimation of the enzyme Aspartate Amino Transferase (AST/SGOT) in serum / plasma.
32Alanine Amino Transferase (ALT/SGPT) test reagents/kitsClass BAn Alanine Amino Transferase (ALT/SGPT) test reagent/kit is a medical device intended for the estimation of enzyme Alanine Amino Transferase (ALT/SGPT) in serum / plasma.
33Sodium test reagents/kitsClass BA Sodium test reagent/kit is a medical device intended for the estimation of sodium in serum/ plasma / urine.
34Total protein test reagents/kitsClass BA Total Protein test reagent/kit is a medical device intended for the estimation of total protein(s) in serum / plasma.
35Protein (fractionation) test reagents/kitsClass BA Protein (fractionation) test reagent/kit is a medical device intended for the estimation of protein fractions in blood, urine, cerebrospinal fluid / other body fluids.
36Protein-bound iodine test reagents/kitsClass BA Protein-bound iodine test reagent/kit is a medical device intended for the estimation of protein-bound iodine in serum / plasma.
37Triglycerides test reagents/kitsClass BA Triglyceride test reagent/kit is a medical device intended for the estimation of triglycerides in serum / plasma.
38Urea (BUN) test reagents/kitsClass BA Urea (BUN) test reagent/kit is a medical device intended for the estimation of urea/Blood Urea Nitrogen (BUN) in plasma/ serum / urine.
39Uric Acid test reagents/kitsClass BA Uric Acid test reagent/kit is a medical device intended for the estimation of uric acid in serum/ plasma / urine.
40Micro-Protein test reagents/kitsClass BA Micro-protein test reagent/kit is a medical device intended for the estimation of micro-proteins including micro-albumin in urine.
41Zinc test reagents/kitsClass BA Zinc test reagent/kit is a medical device intended for the estimation of zinc in serum / plasma.
42Other clinical chemistry test reagents/kitsClass B*Clinical chemistry test reagent/kit intended for the estimation of analytes/ parameters (other than listed above) in serum/ plasma/ urine or other body fluids.
43Hematology Reagents/ Kits for estimation of Complete Blood Counts, exemplified as:Blood cell DiluentsClass BA blood cell Diluent is a medical device used to dilute blood for further testing, such as Complete Blood Count(CBC) .
44Lyse reagents/kits for differential countsClass BA Lyse reagent/kit is a medical device used for lysing of cells for the estimation of Complete Blood Count(CBC).
45Rinse/Detergent/Cleaner s reagents/kitsClass BA Rinse/Detergent/Cleaner reagent/kit is a medical device used for cleaning various parts of Hematology analyzers like probes, needles, baths, tubing etc.
46Reagents/ Kits for estimation of parameters in the urine, exemplified as:Ascorbic Acid/ Bilirubin /Blood Cells/Glucose/ Ketone / Leukocyte peroxidase / Specific gravity/Urobilinogen Nitrite / pH / Protein /Albumin & other urinary analytes test reagents /Strips/kitsClass BAscorbic Acid/ Bilirubin /Blood Cells/Glucose/ Ketone / Leukocyte peroxidase / Specific gravity/Urobilinogen Nitrite/pH /Protein / Albumin & other urinary analytes test reagents /Strips/kits, are medical devices intended for the preliminary estimation of diagnostic markers in urine.
47In – vitro
Diagnostic Medical Devices for Self -Testing
Glucose test reagents/kitsClass BA glucose is a medical reagents/kits device intended for the preliminary self testing of glucose levels in blood/body fluids.
48Human Chorionic Gonadotropin (hCG) test reagents/kitsClass BA human Chorionic Gonadotropin (hCG) test reagent/kit is a medical device intended for the preliminary self testing of hCG in urine/body fluids.
49Luteinizing Hormone (LH) test reagents/kitsClass BA Luteinizing Hormone (LH) test reagent/kit is a medical device intended for the preliminary self testing of Luteinizing Hormone (LH) in urine/body fluids.
50Glycosylated hemoglobinor ist variants Test reagents/kitsClass BGlycosylated Hemoglobin or its variants test reagents/kits are medical devices intended for the preliminary self testing of Glycosylated Hemoglobin or its variants including A1a, A1b, and A1c in blood.
51Cholesterol test reagents/kitsClass BA Cholesterol test reagent/kit is a medical device intended for preliminary self testing of cholesterol in blood /body fluids.
52Follicle Stimulating Hormone (FSH) test reagents/kitsClass BA Follicle Stimulating Hormone (FSH) test reagent/kit is a medical device intended for the preliminary self testing of Follicle Stimulating Hormone (FSH) in urine /body fluids
53Other In – vitro Diagnostic Medical Devices for Self – TestingClass B*
54In – vitro
Diagnostic Medical Device for 55. near patient testing
55Blood Gas Analysis test reagents/kitsClass CA Blood Gas Analysis test reagent/kit for near patient testing, is a medical device intended for the estimation of certain gases (such as oxygen and carbon dioxide etc.) dissolved in arterial blood.
56Anticoagulant monitoring test reagents/kitsClass CAn Anticoagulant monitoring test reagent/kit for near patient testing, is a medical device intended for the estimation of coagulation parameters (such as PT, TT, APTT etc.) in plasma/blood.
57Diabetes management test reagents/kitsClass CA Diabetes management test reagent/kit for near patient testing, is a medical device intended for the of monitoring of diabetes in body fluids.
58C- Reactive Protein (CRP)test reagents/kitsClass CA C- Reactive Protein (CRP) test/kits reagent/kit for near patient testing, is a medical device intended for the estimation of C -Reactive Protein (CRP) in serum and other body fluids
59H. pylori test reagents/kitsClass CAn H. pylori test reagent/kit for near patient testing, is a medical device
intended for the estimation of H. pylori in blood/body fluids.
60Troponin test reagents/kitsClass CA Troponin test reagent/kit for near patient testing, is a medical device
intended for the estimation of Troponin T,I and its variants in blood/body fluids
61Other in vitro Diagnostic Medical Devices for near patient test reagents/kitsClass CIn vitro Diagnostic Medical Device for near patient test reagent/kit intended for the estimation of analytes/ parameters (other than listed above) in serum, plasma, urine or other body fluids.
62Reagents/ Kits for estimation of parameters of ToRCH& other infectious agents exemplified as under:Toxoplasma gondii test reagents/kitsClass CA Toxoplasma gondii test reagent/kit is a medical device intended for the detection of Toxoplasma gondii in serum/body fluids.
63Rubella virus l test reagents/kitsClass CA Rubella virus test reagent/kit is a medical device intended for the detection of Rubella virus in serum/body fluids.
64Cytomegalovirus test reagents/kitsClass CA Cytomegalovirus test reagent/kit is a medical device intended for the detection of Cytomegalovirus in serum/body fluids.
65Herpes simplex virus reagents/kitsClass CA Herpes simplex virus reagent/kit is a medical device intended for the detection of Herpes simplex virus in serum/body fluids.
66Chlamydia pneumoniae test reagents/kitsClass CA Chlamydia pneumoniae test reagent/kit is a medical device intended for the detection of Chlamydia pneumonia in serum/body fluids.
67Methicillin-Resistant Staphylococcus aureus test reagents/kitsClass CA Methicillin-Resistant Staphylococcus aureus test reagent/kit is a medical device intended for the detection of Methicillin-Resistant Staphylococcus aureus in serum/body fluids
68Enterovirus test reagents/kitsClass CAn Enterovirus test reagent/kit medical device intended for the detection of enterovirus) serum/body fluids.
69Reagents/ Kits for detection of Cancer Markers exemplified as :Alpha-fetoprotein test reagents/kitsClass CAn Alpha-fetoprotein test reagent/kit is a medical device intended for the detection of Alpha-fetoprotein in serum/body fluids.
70Beta-2 microglobulin test reagents/kitsClass CA Beta-2 microglobulin test reagent/kit is a medical device intended for the detection of Beta-2 microglobulin in serum/body fluids
71Bladder tumour antigen (BTA) test reagents/kitsClass CA Bladder tumour antigen (BTA) test reagent/kit is a medical device intended for the detection of Bladder tumour antigen (BTA)in serum/body fluids
72CA15-3 test reagents/kitsClass CA CA15-3 antigen (BTA) test reagent/kit is a medical device intended for the detection of CA15-3 in serum/body fluids
73CA27.29 test reagents/kitsClass CA CA27.29 test reagent/kit is a medical device intended for the detection of CA27.29 in serum/body fluids
74CA125 test reagents/kitsClass CA CA125test reagent/kit is a medical device intended for the detection of CA125 in serum/body fluids
75CA72-4 test reagents/kitsClass CA CA72-4 test reagent/kit is a medical device intended for the detection of CA72-4 in serum/body fluids
76CA19-9 test reagents/kitsClass CA CA19-9 test reagent/kit is a medical device intended for the detection of CA19-9 in serum/body fluids
77Calcitonin test reagents/kitsClass CA Calcitonin test reagent/kit is a medical device intended for the detection of Calcitonin in serum/body fluids
78Carcinoembryonic antigen (CEA) test reagents/kitsClass CA Carcinoembryonic antigen (CEA) test reagent/kit is a medical device intended for the detection of Carcinoembryonic antigen (CEA) in serum/body fluids
79Chromogranin A test reagents/kitsClass CA Chromogranin A test reagent/kit is a medical device intended for the detection of Chromogranin A in serum/body fluids
80Estrogen / Progesterone receptors test reagents/kitsClass CA Estrogen / Progesterone test reagent/kit is a medical device intended for the detection of Estrogen / Progesterone in serum/body fluids
81HER2 (Human Epidermal Growth Factor receptor, test reagents/kitsClass CA HER2 (Human Epidermal Growth Factor receptor test reagent/kit is a medical device intended for the detection of HER2 (Human Epidermal Growth Factor receptor in serum/body fluids
82human Chorionic Goadotropin (hCG) test system test reagents/kitsClass CA human Chorionic Goadotropin (hCG) test reagent/kit is a medical device intended for the detection of human Chorionic Goadotropin (hCG) in serum/body fluids
83Lipid associated sialic acid test reagents/kitsClass CA Lipid associated sialic acid test reagent/kit is a medical device intended for the detection of Lipid associated sialic acid in serum/body fluids
84Neuron -Specific Enolase (NSE) test reagents/kitsClass CA Neuron -Specific Enolase (NSE) test reagent/kit is a medical device intended for the detection of Neuron -Specific Enolase (NSE) in serum/body fluids
85NMP22 test reagents/kitsClass CA NMP22 test reagent/kit is a medical device intended for the detection of NMP22 in serum/body fluids
86Prostate-Specific Antigen (PSA) test reagents/kitsClass CA Prostate-Specific Antigen (PSA) test reagent/kit is a medical device intended for the detection of Prostate-Specific Antigen (PSA) in serum/body fluids
87Prostatic Acid Phosphatase (PAP) test reagents/kitsClass CA Prostatic Acid Phosphatase (PAP) test reagents/kits test reagent/kit is a medical device intended for the detection of Prostatic Acid Phosphatase (PAP) test reagents/kits in serum/body fluids
88Prostate Cancer Antigen 3 gene (PCA 3) test reagents/kitsClass CA Prostate Cancer Antigen 3 gene (PCA 3) test reagent/kit is a medical device intended for the detection of Prostate Cancer Antigen 3 gene (PCA 3) in serum/body fluids
89Prostate-Specific Membrane Antigen (PSMA) test reagents/kitsClass CA Prostate-Specific Membrane Antigen (PSMA) test reagent/kit is a medical device intended for the detection of Prostate-Specific Membrane Antigen (PSMA) in serum/body fluids
90S-100 test reagents/kitsClass CA S-100 test reagent/kit is a medical device intended for the detection of S-100 in serum/body fluids
91TA-90 test reagents/kitsClass CA TA-90 test reagent/kit is a medical device intended for the detection of TA-90 in serum/body fluids
92Thyroglobulin test reagents/kitsClass CA Thyroglobulin test reagent/kit is a medical device intended for the detection of Thyroglobulin in serum/body fluids
93Tissue Polypeptide Antigen (TPA) test reagents/kitsClass CA Tissue Polypeptide Antigen (TPA) test reagent/kit is a medical device intended for the detection of Tissue Polypeptide Antigen (TPA) in serum/body fluids
94Other Reagents/ Kits for detection of Cancer MarkersClass C*
95Reagents/ Kits for estimation of Coagulation parameters exemplified as:PT (Prothrombin Time) test reagents/kitsClass CA Prothrombin Time (PT)test reagent/kit is a medical device intended for the estimation of prothrombin time in plasma/body fluids.
96TT (Thrombin Time) test reagents/kitsClass CA Thrombin Time(TT)test reagent/kit is a medical device intended for the estimation of Thrombin Time in plasma/body fluids
97Activated Partial Thromboplastin Time(APTT) testsreagents/kitsClass CA Activated Partial ThromboplastinTime (APTT) test reagent/kit is a medical device intended for the estimation of Activated Partial ThromboplastinTime in plasma/body fluids
98Activated whole blood clotting time tests reagents/kitsClass CA Activated whole blood clotting time test reagent/kit is a medical device intended for the estimation of Activated whole blood clotting Time in plasma/body fluids
99Fibrinogen/Fibrin degradation products tests reagents/kitsClass CA Fibrinogen/Fibrin degradation products test reagent/kit is a medical device intended for the estimation of fibrinogen/fibrin degradation products
100D-Dimer tests reagents/kitsClass CA D-Dimer test reagent/kit is a medical device intended for the estimation of D-Dimer test in plasma/body fluids
101Other Reagents/ Kits for estimation of Coagulation parametersClass C*
102Reagents/ Kits for monitoring of drug levels used for therapy or abuse exemplified as underAminoglycoside antibiot ics test reagents/kitsClass CAminoglycoside antibiotics test reagents/kits are medical devices intended for the estimation of Aminoglycoside antibiotics in serum/body fluids.
103Antiepileptics test reagents/kitsClass CAntiepileptics test reagents/kits are medical devices intended for the estimation of Antiepileptics in serum/body fluids.
104Antipsychotics test reagents/kitsClass CAntipsychotics test reagents/kits are medical devices intended for the estimation of Antipsychotics in serum/body fluids.
105Mood stabilisers, test reagents/kitsClass CMood stabilisers test reagents/kits are medical devices intended for the estimation of Mood stabilisers in serum/body fluids
106Biologic monoclonal antibody drugs test reagents/kitsClass CBiologic monoclonal antibody drugs test reagents/kits are medical devices intended for the estimation of Biologic monoclonal antibody drugs in serum/body fluids
107Buprenorphine (BUP) test reagents/kitsClass CBuprenorphine (BUP) test reagents/kits are medical devices intended for the estimation of Buprenorphine (BUP) in serum/body fluids
108Amphetamine (AMP) test reagents/kitsClass CAmphetamine (AMP) test reagents/kits are medical devices intended for the estimation of Amphetamine (AMP) in serum/body fluids
109Barbiturates ( BAR) test reagents/kitsClass CBarbiturates (BAR) test reagents/kits are medical devices intended for the estimation of Barbiturates (BAR) in serum/body fluids
110Opiate test system test reagents/kitsClass COpiate test reagents/kits are medical devices intended for the estimation of opiates in serum/body fluids
111Benzodiazepines (BZO)Test reagents /kitsClass CBenzodiazepines (BZO) test reagents/kits are medical devices intended for the estimation of Benzodiazepines (BZO) in serum/body fluids
112Cocaine (COC) Test reagents /kitsClass CCocaine (COC) test reagents/kits are medical devices intended for the estimation of Cocaine (COC)in serum/body fluids
113Cotinine (COT) Test reagents /kitsClass CCotinine (COT) test reagents/kits are medical devices intended for the estimation of Cotinine (COT) in serum/body fluids
114Ketamine ( KET )Test reagents /kitsClass CKetamine (KET) test reagents/kits are medical devices intended for the estimation of Ketamine ( KET )in serum/body fluids
115Ecstasy ( MDMA ) Test reagents /kitsClass CEcstasy ( MDMA ) test reagents/kits are medical devices intended for the estimation of Ecstasy ( MDMA )in serum/body fluids
116Methamphetamine ( MET )Test reagents /kitsClass CMethamphetamine ( MET ) test reagents/kits are medical devices intended for the estimation of Methamphetamine (MET) in serum/body fluids
117Morphine ( MOP )Test reagents /kitsClass CMorphine (MOP) test reagents/kits are medical devices intended for the estimation of Morphine (MOP) in serum/body fluids
118Methaqualone (MQL)Test reagents /kitsClass CMethaqualone (MQL) test reagents/kits are medical devices intended for the estimation of Methaqualone (MQL)in serum/body fluids
119Methadone ( MTD) Test reagents /kitsClass CMethadone (MTD)test reagents/kits are medical devices intended for the estimation of Methadone ( MTD )in serum/body fluids
120Oxycodone (OXY)Test reagents /kitsClass COxycodone (OXY) test reagents/kits are medical devices intended for the estimation of Oxycodone (OXY) in serum/body fluids
121Phencyclidine ( PCP ) Test reagents /kitsClass CPhencyclidine (PCP) test reagents/kits are medical devices intended for the estimation of Phencyclidine (PCP)in serum/body fluids
122Propoxyphene ( PPX ) Test reagents /kitsClass CPropoxyphene (PPX) test reagents/kits are medical devices intended for the estimation of Propoxyphene (PPX) in serum/body fluids
123Tricyclic Antidepressants (TCA)Test reagents /kitsClass CTricyclic Antidepressants (TCA) test reagents/kits are medical devices intended for the estimation of Tricyclic Antidepressants (TCA) in serum/body fluids
124Marijuana (THC)Test reagents /kitsClass CMarijuana (THC) test reagents/kits are medical devices intended for the estimation of Marijuana (THC) in serum/body fluids
125Tramadol (TRA ) Test reagents /kitsClass CTramadol (TRA) test reagents/kits are medical devices intended for the estimation of Tramadol (TRA) in serum/body fluids
126Fentanyl (FEN)Test reagents /kitsClass CFentanyl (FEN) test reagents/kits are medical devices intended for the estimation of Fentanyl (FEN) in serum/body fluids
127Methadone Metabolite (EDDP)Test reagents /kitsClass CMethadone Metabolite (EDDP) test reagents/kits are medical devices intended for the estimation of Methadone Metabolite ( EDDP )in serum/body fluids
128Other Reagents/ Kits for monitoring of drug levels used for therapy or abuseClass C*
129Reagents/Kits for detection of autoimmune disorders exemplified as:Anti Nuclear Antibodies test reagents/kitsClass BAnti Nuclear Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to nuclear antigens in human specimens.
130Anti Transglutaminase Antibodies test reagents/kitsClass BAnti Transglutaminase Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Transglutaminase in human specimens.
131Anti Ganglioside Antibodies test reagents/kitsClass BAnti Ganglioside Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Ganglioside in human specimens
132Anti-Cyclic Citrullinated Peptide (CCP) Antibodies test reagents/kitsClass BAnti CyclicCitrullinated Peptide (CCP) Antibodies test reagent/kit is a medical device for the screening of CCP auto-antibodies in human specimens.
133Rheumatoid Factor (RF) immunological test reagents/kitsClass BRheumatoid Factor (RF) immunological test reagent/kit is a medical device for the screening of Rheumatoid Factor in human specimens.
134Anti Smooth Muscle Antibody test reagents/kitsClass BAnti Smooth Muscle Antibody test reagent/kit is a medical device for the screening of auto-antibodies to smooth muscles in human specimens.
135Glutamic Acid Decarboxylase (GAD) Antibody test reagents/kitsClass BGlutamic Acid Decarboxylase (GAD) Antibodytest reagent/kit is a medical device for the screening of auto- antibodies to Glutamic Acid Decarboxylase (in human specimens
136Anti ovary antibodies test reagents/kitsClass BAnti ovary antibodies test reagent/kit is a medical device for the screening of auto-antibodies to ovarian antigens in human specimens
137Anti sperm Antibodies test reagents/kitsClass BAnti sperm antibodies test reagent/kit is a medical device for the screening of auto-antibodies to spermatozoa in human specimens.
138Anti-IA2 test reagents/kitsClass BAnti IA-2 antibodies test reagent/kit is a medical device for the screening of auto-antibodies to IA-2 (tyrosine phosphatase) in human specimens
139Anti-Acetylcholine test reagents/kitsClass BAnti-Acetylcholine Receptor test Receptor reagent/kit is a medical device for the screening of auto-antibodies to Acetylcholine Receptor in human specimens
140Anti Thyroid gland test reagents/kitsClass BAnti Thyroid gland antibodies test antibody reagent/kit is a medical device for the screening of auto-antibodies to thyroid gland antigens in human specimens
141ANCA test reagents/kitsClass BThe ANCA test reagent/kit is a medical device for the screening of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) in human specimens.
142Anti-double stranded DNA (anti-dsDNA)test reagents/kitsClass BThe Anti-double stranded DNA (Anti-dsDNA) test reagent/kit is a medical device for the screening of auto-antibodies to Double stranded DNA in human specimens
143Anti-Extractable Nuclear Antigen(Anti-ENA)test reagents/kitsClass BThe Anti-Extractable Nuclear Antigen(Anti-ENA)test reagent/kit is a medical device for the screening of auto-antibodies to Extractable Nuclear Antigens like Smith (Sm) Antigens, Ribonuclears Protein (RNP), anti SSA (Ro) etc. in human specimens.
144Anti-Intrinsic Factor test reagents/kitsClass BThe Anti-Intrinsic Factor test reagent/kit is a medical device for the screening of antibodies against intrinsic factor in human specimens.
145Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagents/kitsClass BThe Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagent/kit is a medical device for the screening of antibodies against Saccharomyces Cerevisiae in human specimens.
146Other Reagents/ Kits for detection of autoimmune disordersClass B*
147Reagents/Kits for detection of markers for Congenital disorders exemplified as under
148Triple Screen Test reagents/kits for Down’s SyndromeClass CTriple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma.
149Quadruple Screen Test reagents/kits for Down’s SyndromeClass CQuadruple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma
150Chorionic Villus Sample Test reagents/kits for Down’s SyndromeClass CChorionic Villus Sample Test reagent/kit for Down’s Syndrome is a medical device intended for the detection of Down’s Syndrome in body fluids.
151Maternal Serum Alpha- Fetoprotein (MSAFP) test reagents/kits for spina bifidaClass CMaternal Serum Alpha-Fetoprotein (MSAFP) Test reagents/kits for is a medical device intended for the screening of spina bifida in serum.
152Others Reagents/ Kits for detection of Congenital disordersClass C*
153Reagents/Kits for detection of Cardiac Markers exemplified as underCreatine Kinase (CK) and CKMB test reagents/kitsClass BCreatine Kinase (CK) and CKMB test reagent/kit are medical devices intended for the estimation of Creatine Kinase (CK) and CKMB in blood / body fluids.
154Myoglobin test reagents/kitsClass BMyglobin Test reagent/kit for is a medical device intended for the estimation of myglobin in blood /body fluids.
155Troponin test reagents/kitsClass CA Troponin test reagent/kit for near patient testing, is a medical device intended for the estimation of Troponin T,I and its variants in blood /body fluids
156BNP &NT pro BNP test reagents/kitsClass CBNP &NT pro BNP Test reagent/kit for is a medical device intended for theestimation of BNP &NT pro BNP in blood / body fluids
157Reagents/ Kits for human Genetic testing exemplified as:Genetic test reagents/kits for Cystic FibrosisClass CGenetic test reagent/kit for Cystic Fibrosis is a medical device intended for the detection of Cystic Fibrosis in human specimens.
158Genetic test for Huntington’s choreaClass CGenetic test reagent/kit for Huntington’s chorea is a medical device intended for the detection of Huntington’s chorea in human specimens.
159Other Reagents/ Kits for human Genetic testingClass C*
160Reagents/ Kits for the management of life threatening infections exemplified as:HIV Viral Load test reagents/kitsClass CHIV Viral Load test reagent/kit is a medical device intended for the estimation of HIV Viral Load in blood/body fluids
161HBV Viral Load test reagents/kitsClass CHBV Viral Load test reagent/kit is a medical device intended for the estimation of HIV Viral Load in blood/body fluids
162HCV Viral Load test reagents/kitsClass CHCV Viral Load test reagent/kit is a medical device intended for the estimation of HIV Viral Load in blood/body fluids
163CD4 Count & % test reagents/kitsClass CCD4 Count & % test reagent/kit is a medical device intended for the estimation of CD4 Count & % in blood/body fluids.
164CD8 Count & % test reagents/kitsClass CCD8 Count & % test reagent/kit is a medical device intended for the estimation of CD8 Count & % in blood/body fluids.
165CD4/CD8 Ratio test reagents/kitsClass CCD4/CD8 Ratio test reagent/kit are a medical device intended for the estimation of CD4/CD8 Ratio in blood/body fluids.
166Other Reagents/ Kits for the management of life threatening infectionsClass C*
167Reagents/ Kits for the detection of sexually transmitted agent exemplified a underTreponema pallidum test reagents and kitsClass CTreponema pallidum test reagent/kit is a medical device intended for the detection of Treponema pallidum in blood/body fluids.
168Neisseria gonorrhoeae test reagents and kitsClass CNeisseria gonorrhoeae test reagent/kit is a medical device intended for the detection of Neisseria gonorrhoeae in blood/body fluids
169Human Papilloma Virus (HPV) test reagents and kitsClass CHuman Papilloma Virus (HPV) test reagent/kit is a medical device intended for the detection of Human Papilloma Virus in blood/body fluids
170Chlamydia test reagents and kitsClass CChlamydia test reagent/kit is medical device intended for the detection of Chlamydia blood/body fluids
171Herpes Virus test reagents and kitsClass CHerpes Virus test reagent/kit is a medical device intended for the detection of Herpes Virus in blood/body fluids
172Other Reagents/ Kits for the detection of sexually transmitted agentClass C*
173Reagents/ Kits for the Antigen detection of infectious agents with a risk of limited propagation exemplified
as:
174Malaria Antigen test reagents and kitsClass CMalaria Antigen test reagent/kit is a medical device intended for the detection of Malaria Antigen in blood/body fluids
175Dengue virus Antigen test reagents and kitsClass CDengue virus Antigen test reagent/kit is a medical device intended for the detection of Dengue virus Antigen in blood/body fluids
176Chikungunya Antigen test reagents and kitsClass CChikungunya Antigen test reagent/kit is a medical device intended for the detection Chikungunya Antigen of in blood/body fluids
177Leptospira Antigen test reagents and kitsClass CLeptospira Antigen test reagent/kit is a medical device intended for the detection of Leptospira Antigen in blood/body fluids
178Japanese Encephalitis Antigen test reagents and kitsClass CJapanese Encephalitis Antigen test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antigen in blood/body fluids
179Typhoid Antigens test reagents and kitsClass CTyphoid Antigens Test reagent/kit is a medical device intended for the Detection of Typhoid Antigens in blood/body fluids
180Influenza A Antigen test reagents and kitsClass CInfluenza A Antigen test reagent/kit is a medical device intended for the detection of Influenza A Antigen in blood/body fluids
181Influenza B Antigen test reagents and kitsClass CInfluenza B Antigen test reagent/kit is a medical device intended for the detection of Influenza B Antigen in blood/body fluids
182Strep A Antigen test reagents and kitsClass CStrep A Antigen test reagent/kit is a medical device intended for the detection of Strep A Antigen in blood/body fluids
183Strep B Antigen test reagents and kitsClass CStrep B Antigen test reagent/kit is a medical device intended for the detection of Strep B Antigen in blood/body fluids
184Chagas Antigen test reagents and kitsClass CChagas Antigen test reagent/kit is a medical device intended for the detection of Chagas Antigen in blood/body fluids
185Filariasis Antigen test reagents and kitsClass CFilariasis Antigen test reagent/kit is a medical device intended for the detection of Filariasis Antigen in blood/body fluids
186Kala Azar Antigen test reagents and kitsClass CKala Azar Antigen test reagent/kit is a medical device intended for the detection of Kala Azar Antigen in blood/body fluids
187Rotavirus Antigen test reagents and kitsClass CRotavirus Antigen test reagent/kit is a medical device intended for the detection of Rotavirus Antigen in blood/body fluids
188S. pneumonia Antigen test reagents and kitsClass CS. pneumonia Antigen test reagent/kit is a medical device intended for the detection of S. pneumonia Antigen in blood/body fluids
189H. pylori Antigen test reagents and kitsClass CH. pylori Antigen test reagent/kit is a medical device intended for the detection of H. pylori Antigen in blood/body fluids
190Other Reagents/ Kits for the detection of infectious agents with a risk of limited propagationClass C*Reagents/ Kits, other than above, for the Antigen detection of infectious agents with a risk of limited propagation
191Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagation exemplified as under
192Malaria Antibody test reagents and kitsClass BMalaria Antibody test reagent/kit is a medical device intended for the detection of Malaria Antibody in blood/body fluids
193Dengue Antibody test reagents and kitsClass BDengue Antibody test reagent/kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids
194Chikungunya Antibody test reagents and kitsClass BChikungunya Antibody test reagent/kit is a medical device intended for the detection of Chikungunya Antibody in blood/body fluids
195Leptospira Antibody test reagents and kitsClass BLeptospira Antibody test reagent/kit is a medical device intended for the detection of Leptospira Antibody in blood/body fluids
196Japanese Encephalitis Antibody test reagents and kitsClass BJapanese Encephalitis Antibody test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antibody in blood/body fluids
197Typhoid Antibody test reagents and kitsClass BTyphoid Antibody test reagent/kit is a medical device intended for the detection of Typhoid Antibody in blood/body fluids
198Cryptococcus neoformans Antibody test reagents and kitsClass BCryptococcus neoformans Antibody test reagent/kit is a medical device intended for the detection of Cryptococcus neoformans Antibody in blood/body fluids
199Neisseria meningitides Antibody test reagents and kitsClass BNeisseria meningitides Antibody test reagent/kit is a medical device intended for the detection of Neisseria meningitides Antibody in blood/body fluids
200Vibrio cholera Antibody test reagents and kitsClass BVibrio cholera Antibody test reagent/kit is a medical device intended for the detection of Vibrio cholera Antibody in blood/body fluids
201Influenza A Antibody test reagents and kitsClass BInfluenza A Antibody test reagent/kit is a medical device intended for the detection of Influenza A Antibody in blood/body fluids
202Influenza B Antibody test reagents and kitsClass BInfluenza B Antibody test reagent/kit is a medical device intended for the detection of Influenza B Antibody in blood/body fluids
203Strep A Antibody test reagents and kitsClass BStrep A Antibody test reagent/kit is a medical device intended for the detection of Strep A Antibody in blood/body fluids
204Strep B Antibody test reagents and kitsClass BStrep B Antibody test reagents/kits is a medical device intended for the detection of Strep B Antibody in blood/body fluids
205Chagas Antibody test reagents and kitsClass BChagas Antibody test reagent/kit is a medical device intended for the detection of Chagas Antibody in blood/body fluids
206Filariasis Antibody test reagents and kitsClass BFilariasis Antibody test reagent/kit is a medical device intended for the detection of Filariasis Antibody in blood/body fluids
207Kala Azar Antibody test reagents and kitsClass BKala Azar Antibody test reagents/kits is a medical device intended for the detection of Kala Azar Antibody in blood/body fluids
208Rotavirus Antibody test reagents and kitsClass BRotavirus Antibody test reagents/kits is a medical device intended for thedetection of Rotavirus Antibody in blood/body fluids
209S. pneumonia Antibody test reagents and kitsClass BS. pneumonia Antibody test reagent/kit is a medical device intended for the detection of S. pneumonia Antibody in blood/body fluids
210H. pylori Antibody test reagents and kitsClass BH.pylori Antibody test reagent/kit is a medical device intended for the detection of H.pylori Antibody in blood/body fluids
211Other Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagationClass B*
In vitro Diagnostic Medical Devices for Blood Grouping or Tissue Typing
212All other than, the ABO system; the Duffy system; the Kell system; the Kidd system; the Rhesus system, test reagents/kits.Class C
213in vitro Diagnostic Medical Devices for Blood Grouping or Tissue TypingABO System test reagents/kitsClass DIntended for blood grouping or tissue typing.
214Rhesus (D) System test reagents/kitsClass D
215The Duffy system test reagents/kitsClass D
216The Kell system test reagents/kitsClass D
217The Kidd system test reagents/kitsClass D
218HLA test reagents/kitsClass D
219Reagents/Kits for the detection of transmissible agents – screening & confirmatoryHIV test reagents/kitsClass DHIV test reagents/kits is a medical device intended for the detection of HIV in blood/body fluids.
220HBV test reagents/kitsClass DHBV test reagents/kits is a medical device intended for the detection of HBV in blood/body fluids
221HCV test reagents/kitsClass DHCV test reagents/kits is a medical device intended for the detection of HCV in blood/body fluids
222Syphilis screening reagents/kitsClass DSyphilis test reagents/kits is a medical device intended for the screening of Syphilis in blood/body fluids
223Malaria screening reagents/kitsClass DMalaria test reagents/kits is a medical device intended for the screening of Malaria in blood/body fluids
224Other in vitro Medical DevicesTSH test reagents/kitsClass BTSH test reagent/kit is a medical device intended for the estimation TSH in blood/body fluids.
225Total /Free triiodothyronine (T3) test reagents/kitsClass BTotal /Free triiodothyronine (T3) test reagent/kit is a medical device intended for the estimation Total /Free triiodothyronine (T3) in blood/body fluids
226Total / Free thyroxine (T4) test reagents/kitsClass BTotal / Free thyroxine (T4) test reagent / kit is a medical device intended for the estimation of Total / Free thyroxine (T4) in blood/body
227Dehydroepiandrosterone (DHEA-S) (free and sulfate) test reagents/kitsClass BDehydroepiandrosterone (DHEA-S) (free and sulfate) test reagent/kit is a medical device intended for the estimation of DHEA-S (free and sulfate) in blood/body fluids
228Estrogen test reagents/kitsClass BEstrogen test reagent/kit is a medical device intended for the estimation of Estrogen in blood/body fluids
229Progesterone test reagents/kitsClass BProgesterone test reagent/kit is a medical device intended for the estimation of Progesterone in blood/body fluids
230Testosterone (Free and Total) test reagents/kitsClass BTestosterone (Free and Total) test reagent/kit is a medical device intended for the estimation of Testosterone (Free and Total) in blood/body fluids
231Sex Hormone Binding Globulin (SHBG) test reagents/kitsClass BSex Hormone Binding Globulin (SHBG) test reagent/kit is a medical device intended for the estimation of Sex Hormone Binding Globulin (SHBG) in blood/body fluids
232Cortisol test reagents/kitsClass BCortisol test reagent/kit is a medical device intended for the estimation of Cortisol in blood/body fluids
233Insulin test reagents/kitsClass BInsulin test reagent/kit is a medical device intended for the estimation of Insulin in blood/body fluids
234Luteinizing Hormone(LH) test reagents/kitsClass BLuteinizing Hormones (LH) test reagent/kit is a medical device intended for the estimation of Luteinizing Hormone (LH) in blood/body fluids
235Follicle Stimulating Hormone(FSH) test reagents/kitsClass BFollicle Stimulating Hormone (FSH) test reagent/kit is a medical device intended for the estimation of Follicle Stimulating Hormone (FSH) in blood/body fluids
236Prolactin test reagents/kitsClass BProlactin test reagent/kit is a medical device intended for the estimation of Prolactin in blood/body fluids
237Other test reagents/kits for hormonesClass BTest reagents/kits for the estimation of other than above hormones in blood/body fluids
238Vitamin B test reagents/kitsClass BVitamin B test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids
239Vitamin D test reagents/kitsClass BVitamin D test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids
240Vitamin A test reagents/kitsClass BVitamin A test reagent/kit is a medical device intended for the estimation of Vitamin A in blood/body fluids
241Vitamin E test reagents/kitsClass BVitamin E test reagent/kit is a medical device intended for the estimation of Vitamin E in blood/body fluids
242Vitamin K test reagents/kitsClass BVitamin K test reagent/kit is a medical device intended for the estimation of Vitamin K in blood/body fluids
243Other test reagents/kits for vitaminsClass BTest reagents/kits for the estimation of other than above vitamins in blood/body fluids
244Homocystein test reagents/kitsClass BHomocystein test reagent/kit is a medical device intended for the estimation of Homocystein in blood/body fluids
245allergens test reagents/kitsClass BTest reagents/kits intended for the estimation of allergens in blood/body fluids
246calibrators/co ntrols for above all in vitro diagnostic medical devicesCalibratorsCalibrators intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent.
247ControlsControls intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent

Note: Anticoagulant Solutions, Embolization Particles, chitosan scaffold (for cartilage repair), Riboflavin (for Corneal Collagen cross-linking), silicone oil endotamponade, Intraocular Gases and Injectable Fillers shall be regulated as drugs under the provisions of the Drugs and Cosmetics Act, and Drugs and Cosmetics Rules, 1945.

 

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