Importer / authorised agent · Tamil Nadu · India

Becton Dickinson India Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
1,328
Manufacturing
34
Import
1,294
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices248
Class BLow–moderate risk543
Class CModerate–high risk513
Class D (high risk)Highest-risk devices24

CDSCO device licences

Evacuated Blood Collection Tube · Class AIMPORT · 2026-04-27

BD Vacutainer Fluoride Blood Collection Tubes are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation and transp…

IMP/IVD/2022/000325 · from United States
Evacuated Blood Collection Tube · Class AIMPORT · 2026-04-27

BD Vacutainer Fluoride Blood Collection Tubes are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment. preservation and trans…

IMP/IVD/2022/000325 · from United States
Evacuated Blood Collection Tube · Class AIMPORT · 2026-04-27

BD Vacutainer Fluoride Blood Collection Tubes are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation and transp…

IMP/IVD/2022/000325 · from United Kingdom
Disposable Hypodermic Needles · Class BIMPORT · 2026-04-16

It is used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin

IMP/MD/2019/000178 · from United States
Disposable Hypodermic Syringes · Class BIMPORT · 2026-04-16

It is used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.

IMP/MD/2019/000178 · from United States
Disposable Hypodermic Syringes · Class BIMPORT · 2026-04-16

It is used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.

IMP/MD/2019/000178 · from United States
Disposable Hypodermic Syringes with Needles · Class BIMPORT · 2026-04-06

Injection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).

IMP/MD/2020/000121 · from Spain
Disposable Hypodermic Syringes · Class BIMPORT · 2026-04-06

Injection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs)

IMP/MD/2020/000121 · from Spain
BD Oral/Enteral Tip Cap with BD UniVia Connection · Class AIMPORT · 2026-04-06

The BD Oral Tip Cap is intended to be used by the healthcare professionals to prevent the contents from leaking from the tip of the BD Oral/Enteral syringe during storage and transportation

IMP/MD/2019/000178 · from United States
Auto-Disable Syringes · Class BIMPORT · 2026-04-06

Injection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).

IMP/MD/2020/000121 · from Spain
BD Oral/Enteral Syringe with BD UniVia Connection · Class BIMPORT · 2026-04-06

BD? Oral / Enteral Syringe with BD UniVia? connection is intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.

IMP/MD/2019/000178 · from United States
Disposable Hypodermic Needle · Class BIMPORT · 2026-04-06

Injection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs)

IMP/MD/2020/000121 · from Spain
Disposable Hypodermic Syringes with Needles · Class BIMPORT · 2026-04-06

Injection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).

IMP/MD/2020/000121 · from Spain
Disposable Hypodermic Syringes · Class BIMPORT · 2026-04-06

Injection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).

IMP/MD/2020/000121 · from Spain
Disinfecting Cap · Class BIMPORT · 2026-03-16

BD PureHub? Disinfecting Caps are intended to be used as a disinfecting device for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses.

IMP/MD/2019/000178 · from United States
Syringe Tip Cap · Class AIMPORT · 2026-03-16

To Prevent Leakage of the Syringe content and to maintain sterility until the syringe is used.

IMP/MD/2019/000178 · from United States
Disposable Hypodermic Syringes · Class BIMPORT · 2026-03-09

It is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals

IMP/MD/2020/000225 · from Singapore
Disposable Hypodermic Syringes · Class BIMPORT · 2026-03-09

It is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals

IMP/MD/2020/000225 · from Singapore
Disposable Hypodermic Needle · Class BIMPORT · 2026-03-09

It is intended for single use, the sterile device is designed for the hypodermic administration of pharmaceuticals

IMP/MD/2020/000225 · from Singapore
Disposable Hypodermic Syringes · Class BIMPORT · 2026-03-09

It is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals

IMP/MD/2020/000225 · from Singapore
Prefillable Injection system · Class BIMPORT · 2026-03-09

The Uniject Prefillable Injection System is a disposable system for the parenteral administration of drugs and vaccines which also serves as a container for the drugs

IMP/MD/2020/000225 · from Singapore
Disposable Hypodermic Syringes · Class BIMPORT · 2026-03-09

It is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals.

IMP/MD/2020/000225 · from Singapore
Disposable Hypodermic Needle · Class BIMPORT · 2026-01-30

Intended for Aspiration of Fluids from Vials and ampoules. Not for Skin Injection

IMP/MD/2019/000178 · from United States
Flush Syringe · Class CIMPORT · 2026-01-30

For use in maintaining patency of vascular access devices (for Flushing only)

IMP/MD/2019/000178 · from United States
Intravascular Access Device (BD Q-Syte) · Class BIMPORT · 2026-01-30

The BD Q-Syte? Luer access split septum are intended for use an accessory to an intravascular administration set that permits injection, gravity flow, and withdrawal of fluids.

IMP/MD/2020/000179 · from Mexico
Heparin Lock Flush Syringe · Class CIMPORT · 2026-01-30

For use in maintaining patency of vascular access devices (for Flushing only)

IMP/MD/2019/000178 · from United States
Disposable Hypodermic Needle · Class BIMPORT · 2026-01-30

Intended for Aspiration of Fluids from Vials and ampoules. Not for Skin Injection

IMP/MD/2019/000178 · from United States
Stopcock · Class BIMPORT · 2026-01-15

BD Connecta? Stopcock with a BD Q-Syte? needle-free connector is used to administer fluids or medications through one or two different ports via an IV cannula or extension tube. Both ports can be used to sample blood and the port without th…

IMP/MD/2025/000065 · from Mexico
BD SurePath Collection Vial Kit 500 · Class AIMPORT · 2026-01-05

BD SurePath? Collection Vial Kit 500 is designed for use with BD PrepStain and BD Totalys Systems for the processing of BD SurePath liquid-based Pap tests.

IMP/IVD/2019/000174 · from United States
BD Density Reagent · Class BIMPORT · 2026-01-05

BD Density Reagent is a polysaccharide solution used in the SurePath® cell enrichment process. An enrichment step, consisting of centrifugal sedimentation through Density Reagent, partially removes non-diagnostic debris and excess inflammat…

IMP/IVD/2019/000174 · from United States
BD CytoRich Red Preservative · Class AIMPORT · 2026-01-05

BD CytoRich Red Preservative is intended to preserve cells and small tissue fragments in suspension. It is also used to prepare cells and small tissue fragments for cytological and histological examination. It lyses red blood cells and sol…

IMP/IVD/2019/000174 · from United States
BD PrepStain Install Kit · Class CIMPORT · 2026-01-05

BD PrepStain? Install Kit contains: BD Alcohol Blend Rinse, BD SurePath? Preservative Fluid, BD Cytology Stain Kit, BD Settling Chambers, BD SurePath? PreCoat Slides, BD PrepStain Transfer Tips, Nalgene Bottles and Caps, Tris Buffered Salin…

IMP/IVD/2019/000174 · from United States
BD Non-GYN Stain Kit · Class CIMPORT · 2026-01-05

The BD Non-GYN Stain Kit contains: BD Hematoxylin Stain 0.5 and BD EA/OG Combo Stain. The kit is used in the staining procedure for the preparation of non-gynaecological samples.

IMP/IVD/2019/000174 · from United States
BD SurePathTM Preservative Fluid · Class BIMPORT · 2026-01-05

BD SurePathTM Preservative Fluid is an alcohol-based preservative fluid intended for the collection, preparation and examination of specimens from a human body for diagnostic purposes.

IMP/IVD/2019/000174 · from United States
BD Alcohol Blend Rinse · Class AIMPORT · 2026-01-05

BD Alcohol Blend Rinse is a reagent used as an alcohol wash during the preparation of SurePath® Pap Test slides.

IMP/IVD/2019/000174 · from United States
BD SurePath PreCoat Slides · Class BIMPORT · 2026-01-05

BD SurePath PreCoat Slides are coated to create a positive charge on the slide surface. This positive charge enables adhesion of the negatively charged diagnostic cytological material to the slide throughout the slide preparation process.

IMP/IVD/2019/000174 · from United States
BD PrepMate Install Kit · Class BIMPORT · 2026-01-05

BD PrepMate Install Kit Contains BD Density reagent, Bd 4ml Dispenser, dispenser tubings, BD Centrifuge tubes, BD Syringing pipettes empty vials and caps. This kit is intended to be used by authorized personnel during installation of PrepMa…

IMP/IVD/2019/000174 · from United States
BD PrepStain? Consumables Kit · Class CIMPORT · 2026-01-05

BD PrepStain? Consumables Kit contains BD Surepath PreCoat Slides, BD Transfer tips and BD settling Chambers. BD PrepStain? Consumables Kit is for use with the BD PrepStain? System.

IMP/IVD/2019/000174 · from United States
BD Cytology Stain Kit · Class BIMPORT · 2026-01-05

BD Cytology Stain Kit contains BD Hematoxylin Stain 0.75 and BD EA/OG Combo Stain. The Cytology Stain Kit is used in the Papanicolaou staining procedure for the preparation of SurePath Pap Test Slides.

IMP/IVD/2019/000174 · from United States
BD PrepMate Consumables Kit · Class CIMPORT · 2026-01-05

BD PrepMate? Consumables Kit contains BD Density Reagent, BD Centrifuge Tubes, BD Syringing Pipettes and BD Aspirator Tips. It is intended for use with the BO PrepMate? Automated Accessory.

IMP/IVD/2019/000174 · from United States
BD SurePath Direct to Slide Kit · Class CIMPORT · 2026-01-05

The BD SurePath? Direct to Slide Kit method produces a Liquid Based Cytology (LBC) slide appropriate for use in the morphological evaluation of cervical samples.

IMP/IVD/2019/000174 · from United States
BD PrepStain Non-GYN Test Kit · Class CIMPORT · 2026-01-05

It is an alcohol-based preservative fluid intended for preservation of cytology cells in suspension and their subsequent preparation for cytological evaluation.

IMP/IVD/2019/000174 · from United States
Disposable Hypodermic Syringes · Class BIMPORT · 2025-12-29

Intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolites, co-oximetry and other tests.

IMP/MD/2018/000434 · from United Kingdom
Disposable Hypodermic Needles · Class BIMPORT · 2025-12-29

Intended to be used for sampling of venous blood derived from the human body for the purpose of in-vitro diagnostic examination

IMP/MD/2018/000434 · from United Kingdom
Disposable Hypodermic syringes · Class BIMPORT · 2025-12-29

Intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolites, co-oximetry and other tests.

IMP/MD/2018/000434 · from United Kingdom
BD BBL? MycoPrepKits · Class CIMPORT · 2025-12-18

The BD BBL? MycoPrep? Kits are used for the digestion and decontamination of clinical specimens suspected to contain mycobacteria, especially Mycobacterium tuberculosis.

IMP/IVD/2019/000065 · from United States
IV Catheters · Class BIMPORT · 2025-11-13

The BD Nexiva intravascular catheter is inserted into a patient?s vascular system for short term (less than 30 days) to sample blood, monitor blood pressure or administer fluids intravascularly. The needle shielding feature and luer access …

IMP/MD/2020/000179 · from United States
Chronic Drainage Accessories · Class BIMPORT · 2025-11-12

The Catheter Access Kit is intended to provide access to the PeritX? Catheter for aspiration and catheter maintenance. The Catheter Access Kit is intended to provide access to the PleurX? Catheter to inject and withdraw fluids.

IMP/MD/2020/000257 · from United States
Disposable Hypodermic Needle · Class BIMPORT · 2025-11-12

Used as a component for the production of other Medical devices and after sterilization intended for Injection and/or aspiration of medical fluids (Corporal fluids Blood, etc) and drugs

IMP/MD/2020/000508 · from Singapore
Chronic Drainage Accessories · Class BIMPORT · 2025-11-12

The Lockable Drainage Line Kit is indicated for use only with the PleurX? Catheter and PeritX? Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system…

IMP/MD/2020/000257 · from Dominican Republic

Global footprint

Cross-rail

The same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.

No FDA clearances linked — India-domestic footprint.

Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.

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