Becton Dickinson India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 248 |
| Class B | Low–moderate risk | 543 |
| Class C | Moderate–high risk | 513 |
| Class D (high risk) | Highest-risk devices | 24 |
CDSCO device licences
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 StatesBD 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 StatesBD 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 KingdomIt 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 StatesIt 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 StatesIt 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 StatesInjection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).
IMP/MD/2020/000121 · from SpainInjection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs)
IMP/MD/2020/000121 · from SpainThe 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 StatesInjection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).
IMP/MD/2020/000121 · from SpainBD? 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 StatesInjection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs)
IMP/MD/2020/000121 · from SpainInjection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).
IMP/MD/2020/000121 · from SpainInjection and/or aspiration of medical fluids (corporal fluids (Blood, ets) and drugs).
IMP/MD/2020/000121 · from SpainBD 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 StatesTo Prevent Leakage of the Syringe content and to maintain sterility until the syringe is used.
IMP/MD/2019/000178 · from United StatesIt is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals
IMP/MD/2020/000225 · from SingaporeIt is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals
IMP/MD/2020/000225 · from SingaporeIt is intended for single use, the sterile device is designed for the hypodermic administration of pharmaceuticals
IMP/MD/2020/000225 · from SingaporeIt is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals
IMP/MD/2020/000225 · from SingaporeThe 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 SingaporeIt is intended for general purpose injection and aspiration of medical fluids, or pharmaceuticals.
IMP/MD/2020/000225 · from SingaporeIntended for Aspiration of Fluids from Vials and ampoules. Not for Skin Injection
IMP/MD/2019/000178 · from United StatesFor use in maintaining patency of vascular access devices (for Flushing only)
IMP/MD/2019/000178 · from United StatesThe 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 MexicoFor use in maintaining patency of vascular access devices (for Flushing only)
IMP/MD/2019/000178 · from United StatesIntended for Aspiration of Fluids from Vials and ampoules. Not for Skin Injection
IMP/MD/2019/000178 · from United StatesBD 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 MexicoBD 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 StatesBD 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 StatesBD 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 StatesBD 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 StatesThe 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 StatesBD 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 StatesBD 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 StatesBD 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 StatesBD 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 StatesBD 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 StatesBD 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 StatesBD 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 StatesThe 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 StatesIt 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 StatesIntended 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 KingdomIntended 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 KingdomIntended 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 KingdomThe 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 StatesThe 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 StatesThe 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 StatesUsed 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 SingaporeThe 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 RepublicGlobal footprint
Cross-railThe 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.