EMED SP. Z O. O. SP. K.
PL-MF-000012648 · Poland · Opacz Kolonia
EMED SP. Z O. O. SP. K. is registered in the European database on medical devices as a manufacturer, with 349 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 248 |
|---|---|
| Class IIa | 101 |
Among these devices, 27 are declared sterile, 21 reusable, 250 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 349 |
| Country of registration | Poland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0034/4919/2025 | supplemented | 2028-05-05 |