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: FG-07, HYPERION, LE-13, LM-01.4, SU-03.
Among these devices, 524 are declared active, 8 with a measuring function.
Devices declared under this manufacturer
- AS-08.0 Poszerzenie blatu
- AS-69.1 Blat do operacji ręki
- Fotel ginekologiczny FG-07
- MC-48 Wydłużenie do materaca
- OT-SVH04BN2 Podgłówek dwupłaszczyznowy
- SG-43.3 Podnóżki dzielone, podwójnie odwodzone
- Stół operacyjny SU-03
- Stół operacyjny SU-05
- WS-14.5 Uchwyt przewodów anestezjologicznych
- WS-30.8 Pozycjoner proktologiczny
- WS-60.6 Wałek przeciwtrakcyjny z podporą ud
- WS-82.7 Klamra na wyciąg ortopedyczny
Showing 12 of 527 declared devices.
Catalogue references include AS-08.0, FG-07, OT-SVH04BN2, SU-03, SU-05, WS-14.5.
European nomenclature codes declared: V08068099, Z12011202, V08060101, V08050101, V08060105, V080602.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 527 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 527 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. FAMED ŻYWIEC SP. Z O.O. was not found in either the U.S. or the Canadian register.
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 |