Poly Medicure Limited
Faridabad, IN
POLY MEDICURE LIMITED appears in FDA device records in Faridabad, IN. FDA records list 6 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Poly Medicure Limited between 2023 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K252677 | Polyshield Safety IV Catheters | FOZ | Substantially Equivalent | |
| K232234 | Nouvo Safety Set | FOZ | Substantially Equivalent | |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | FOZ | Substantially Equivalent | |
| K230616 | Polyguard and Polyshield Safety IV Catheters | FOZ | Substantially Equivalent | |
| K220312 | Polyfusion IV Administration Sets | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017210006 | 3017210006 | POLY MEDICURE LIMITED | Plot No. 33-34, Sector-68, IMT, Faridabad Haryana 121004 IN | 2026 | |
| 3018159714 | 3018159714 | POLY MEDICURE LTD | Plot No. PA010-018 & 010-019, Jaipur Rajasthan 302037 IN | 2026 | |
| 9616991 | 3003205539 | POLY MEDICURE LTD. | Plot No. 115, 116 & 117, Sector 59, HSIIDC Industrial area, Faridabad Haryana 121004 IN | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- CAEAirway, Oropharyngeal, Anesthesiology
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KXGApplicator, Absorbent Tipped, Sterile
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- KDQBottle, Collection, Vacuum
- GECBrush, Scrub, Operating-Room
- CATCannula, Nasal, Oxygen
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- GAANeedle, Aspiration And Injection, Disposable
- FPASet, Administration, Intravascular
- PYGSuction Catheter Kit
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain