POLY MEDICURE LIMITED
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 257 |
| Class B | Low–moderate risk | 2,111 |
| Class C | Moderate–high risk | 179 |
| Class D (high risk) | Highest-risk devices | 52 |
CDSCO device licences
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 · RajasthanA 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 · RajasthanA 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 · RajasthanA 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 · RajasthanThe Introducer Sheath is used to facilitate placing a catheter through the skin into the radial artery.
MFG/MD/2020/000183A 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/2020/000183A 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/2020/000183IV 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 · UttarakhandIt is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018For 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/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018:It is indicated for the collection and preservation of leuko-depleted human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018For 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/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018:It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and transfusion of leuko-depleted human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018It is indicated for the collection and preservation of human blood and blood components.
MFG/MD/2021/000018The 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/2020/000183PTCA 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/2020/000183Aspiration Catheter is intended for the removal of fresh, soft thrombi in patients with large residual thrombus burden undergoing primary percutaneous coronary intervention.
MFG/MD/2020/000183The 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/2020/000183Intended for monitoring central venous pressure (CVP), sampling blood, and simultaneous administration of multiple IV solutions or drugs.
MFG/MD/2019/000086 · HaryanaIntended 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 · HaryanaTo connect blood lines with the blood vessels through needles when dialysis is carried out
MFG/MD/2018/000032 · HaryanaIt can be used to connect to a perfusion sets or catheter for infusion of contrast media etc.
MFG/MD/2018/000032 · HaryanaIntended for monitoring central venous pressure (CVP), sampling blood, and simultaneous administration of multiple IV solutions or drugs.
MFG/MD/2019/000086 · HaryanaIntended 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 · HaryanaA subcutaneous injection is a method of administering medication.
MFG/MD/2019/000086 · HaryanaTo connect blood lines with the blood vessels through needles when dialysis is carried out
MFG/MD/2018/000032 · HaryanaSkin stapler is intended to be applied to close lacerations on the outer layer of the dermis.
MFG/MD/2018/000032 · HaryanaIntended 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 · HaryanaIntended 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 · HaryanaIV 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 · UttarakhandThe 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/2020/000183Global 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.