FAE Famed Łódź S.A.
PL-MF-000018775 · Poland · Łódź
FAE Famed Łódź S.A. is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 52 |
|---|
Among these devices, 52 are declared active.
Devices declared under this manufacturer
- HELIOS 160 FA
- HELIOS 160/60 C
- HELIOS-M 160 C
- IGNIS 160 FA
- SOLIS 130FA
- SOLIS 160 C
- SOLIS 160 FA
- SOLIS 30 C
- SOLIS 30 F
- SOLIS 30 W
- SOLIS 60 W
- SOLIS 60/60 W
Showing 12 of 52 declared devices.
Catalogue references include HELIOS 160 FA, IGNIS 160 FA, SOLIS 160 FA, SOLIS 30 C, SOLIS 30 F, SOLIS 30 W.
European nomenclature codes declared: Z12010701, Z12011202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 52 |
| 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 | 52 |
|---|---|
| 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. FAE Famed Łódź S.A. was not found in either the U.S. or the Canadian register.