Medical Device Manufacturer · IN , Jaipur

Poly Medicure Limited - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2023

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Poly Medicure Limited General Hospital ✕

6 devices

1-6 of 6

Regulatory consultants 510(k) submission support ecosystem

Gsa2 Group, LLC

Donawa Lifescience Consulting Srl

Donawa Lifescience

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 06, 2026