Domestic manufacturer · Uttarakhand · India

POLY MEDICURE LIMITED

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
2,599
Manufacturing
2,589
Import
10
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices257
Class BLow–moderate risk2,111
Class CModerate–high risk179
Class D (high risk)Highest-risk devices52

CDSCO device licences

Under Water Seal Drainage Bottle · Class BMFG · 2026-05-01

A 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.

MFG/MD/2021/000139 · Rajasthan
Under Water Seal Drainage Bottle · Class BMFG · 2026-05-01

A 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.

MFG/MD/2021/000139 · Rajasthan
Closed wound drainage system · Class BMFG · 2026-05-01

A 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.

MFG/MD/2021/000139 · Rajasthan
Under Water Seal Drainage Bottle · Class BMFG · 2026-05-01

A 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

MFG/MD/2021/000139 · Rajasthan
Introducer Sheath · Class CMFG · 2026-04-24

The Introducer Sheath is used to facilitate placing a catheter through the skin into the radial artery.

MFG/MD/2020/000183
Non-Compliant PTCA Balloon Dilatation Catheter · Class DMFG · 2026-04-23

A Non-Compliant PTCA Balloon Dilatation catheter 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 p…

MFG/MD/2020/000183
Semi-Compliant PTCA Balloon Dilatation Catheter · Class DMFG · 2026-04-23

A PTCA catheter 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.

MFG/MD/2020/000183
I.V. Cannula for Quick flashback · Class BMFG · 2026-04-08

IV Cannula is inserted into a vein, mainly for the administration of intravenous fluids, withdrawal of blood samples and to deliver Intravenous fluid and medicines into human circulating.

MFG/MD/2025/000647 · Uttarakhand
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution IP · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution USP with Leukocyte filter (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution IP & additive SAGM solution with Leukocyte filter · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Dextrose Solution USP ACD Solution (A) (For Export Only) · Class CMFG · 2026-04-06

For use with automated pheresis equipment in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution IP for umbilical cord Blood · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood bag with Leukocyte filter (Lab side) · Class CMFG · 2026-04-06

:It is indicated for the collection and preservation of leuko-depleted human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution USP additive SAGM-II solution (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Dextrose Solution IP, ACD Solution (A) · Class CMFG · 2026-04-06

For use with automated pheresis equipment in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution IP with Leukocyte filter · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution IP & additive solution ADSOL · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution IP · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution IP & additive SAGM solution · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Transfer Bag · Class CMFG · 2026-04-06

:It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution USP & additive SAGM solution (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution USP & additive solution ADSOL (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution USP for umbilical cord Blood (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution USP & additive SAGM solution with Leukocyte filter (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution USP & additive SAGM solution with Leukocyte filter (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution IP & additive SAGM II solution · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution IP & additive SAGM solution with Leukocyte filter · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution USP (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Leukocyte filter (Bed side) · Class CMFG · 2026-04-06

It is indicated for the collection and transfusion of leuko-depleted human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution USP (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution USP & additive SAGM solution (For Export Only) · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA/CPDA-1) Solution IP & additive SAGM solution · Class CMFG · 2026-04-06

It is indicated for the collection and preservation of human blood and blood components.

MFG/MD/2021/000018
OTW Non-Compliant Balloon Dilatation catheter · Class DMFG · 2026-03-27

The OTW Non-Compliant Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

MFG/MD/2020/000183
PTCA Guidewire · Class DMFG · 2026-03-27

PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTCA/PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. This guide wire may al…

MFG/MD/2020/000183
Aspiration Catheter · Class DMFG · 2026-03-27

Aspiration Catheter is intended for the removal of fresh, soft thrombi in patients with large residual thrombus burden undergoing primary percutaneous coronary intervention.

MFG/MD/2020/000183
OTW Semi-Compliant Balloon Dilatation catheter · Class DMFG · 2026-03-27

The OTW Non-Compliant Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

MFG/MD/2020/000183
Multiple Lumen Catheter · Class BMFG · 2026-03-26

Intended for monitoring central venous pressure (CVP), sampling blood, and simultaneous administration of multiple IV solutions or drugs.

MFG/MD/2019/000086 · Haryana
Gastro-Urology Needle · Class BMFG · 2026-03-26

Intended for gastroenterology biopsy, Automatic Biopsy Devices are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bon…

MFG/MD/2019/000086 · Haryana
Fistula Needle · Class BMFG · 2026-03-26

To connect blood lines with the blood vessels through needles when dialysis is carried out

MFG/MD/2018/000032 · Haryana
Y-Connector as an accessory to perfusion set · Class AMFG · 2026-03-26

It can be used to connect to a perfusion sets or catheter for infusion of contrast media etc.

MFG/MD/2018/000032 · Haryana
Multiple Lumen Catheter · Class BMFG · 2026-03-26

Intended for monitoring central venous pressure (CVP), sampling blood, and simultaneous administration of multiple IV solutions or drugs.

MFG/MD/2019/000086 · Haryana
Gastro-Urology Needle · Class BMFG · 2026-03-26

Intended for gastroenterology biopsy, Automatic Biopsy Devices are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bon…

MFG/MD/2018/000032 · Haryana
Huber Needle · Class BMFG · 2026-03-26

A subcutaneous injection is a method of administering medication.

MFG/MD/2019/000086 · Haryana
Fistula Needle · Class BMFG · 2026-03-26

To connect blood lines with the blood vessels through needles when dialysis is carried out

MFG/MD/2018/000032 · Haryana
Skin Stapler · Class BMFG · 2026-03-26

Skin stapler is intended to be applied to close lacerations on the outer layer of the dermis.

MFG/MD/2018/000032 · Haryana
Gastro-Urology Needle · Class BMFG · 2026-03-26

Intended for gastroenterology biopsy, Co-Axial Biopsy Needle is mainly used to guide the insertion of biopsy Needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is not intended for use in bone.

MFG/MD/2018/000032 · Haryana
Gastro-Urology Needle · Class BMFG · 2026-03-26

Intended for gastroenterology biopsy, Co-Axial Biopsy Needle is mainly used to guide the insertion of biopsy Needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is not intended for use in bone.

MFG/MD/2019/000086 · Haryana
I.V. Cannula for Quick flashback · Class BMFG · 2026-03-24

IV Cannula is inserted into a vein, mainly for the administration of intravenous fluids, withdrawal of blood samples and to deliver Intravenous fluid and medicines into human circulating.

MFG/MD/2025/000647 · Uttarakhand
Pre-filled syringe 0.9% Sodium Chloride (0.9% NaCl) · Class CMFG · 2026-03-23

The Prefilled Syringes - Normal Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices and intended for use in maintaining patency of vascular access devices (VAD's).

MFG/MD/2020/000183

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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