FAMED ŻYWIEC SP. Z O.O.
PL-MF-000002794 · Poland · Żywiec
FAMED ŻYWIEC SP. Z O.O. is registered in the European database on medical devices as a manufacturer, with 527 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 527 |
|---|
Most frequent device types declared: SU-03, SU-05 , WUL-00, WUW-00, WK-00.
Among these devices, 524 are declared active, 8 with a measuring function.
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 | 527 |
| 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/003/0139/2022 | issued | 2025-11-13 |
HZ 1436271-1 | issued | 2025-11-13 |
HZ 1436271-1 | reissued | 2030-11-13 |