Data / Medical devices / India / Poly Medicure Ltd.
Poly Medicure Ltd.: FDA-registered device maker in Faridabad Haryana, India, 5 510(k) clearances
Poly Medicure Ltd. is registered with the FDA (registration 9616991) in Faridabad Haryana, India. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 1, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9616991
- FEI number
- 3003205539
- Address
- Plot No. 115, 116 & 117, Sector 59, HSIIDC Industrial area Ballabgarh, Faridabad Haryana, India, 121004
- Owner or operator
- Poly Medicure Limited (9044462)
- Roles
- Manufacturer
- First device listed
- February 24, 2017
- Registered through
- 2027
- Brand names listed
- POLYMED, Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva, Polyshield Safety IV Catheters, Polyshield, Polyshield Adva, Polyshield BC, Polyshield BC Adva, Polyguard+, Polyguard Adva, Polyguard BC, Polyguard BC Adva, Polywin Safety and Polywin Safety Adva IV Catheter, Safety Vac, Safety-Vac Sterile Connection Tube, Ultravak Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 1, 2026 | K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | FOZ | Substantially Equivalent | Poly Medicure Limited | accessdata.fda.gov |
| November 5, 2025 | K252677 | Polyshield Safety IV Catheters | FOZ | Substantially Equivalent | Poly Medicure Limited | accessdata.fda.gov |
| March 15, 2024 | K232234 | Nouvo Safety Set | FOZ | Substantially Equivalent | Poly Medicure Limited | accessdata.fda.gov |
| September 21, 2023 | K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | FOZ | Substantially Equivalent | Poly Medicure Limited | accessdata.fda.gov |
| May 5, 2023 | K230616 | Polyguard and Polyshield Safety IV Catheters | FOZ | Substantially Equivalent | Poly Medicure Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Accessories, Catheter
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
- All makers of Airway, Oropharyngeal, Anesthesiology
Updated April 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.