SEMA Spółka Cywilna Sergiusz Albiński, Magdalena Albińska
PL-MF-000048470 · Poland · Częstochowa
SEMA Spółka Cywilna Sergiusz Albiński, Magdalena Albińska is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 22 |
|---|
Most frequent device types declared: Jednorazowe podkłady ochronne.
Devices declared under this manufacturer
- Univel® Plus 50x160 cm
- Univel® Plus 50x80 cm
Showing 12 of 22 declared devices.
Catalogue references include UP 01 - 50/160/25, UP 11 - 50/160/25, UP 11 - 50/80/50, UP 33 - 50/160/25, UP 44 - 50/160/25, UP 44 - 50/80/50.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 22 |
| 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 | 22 |
|---|---|
| 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. SEMA Spółka Cywilna Sergiusz Albiński, Magdalena Albińska was not found in either the U.S. or the Canadian register.