SILVERMARK SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000054565 · Poland · Bydgoszcz
SILVERMARK SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 26 |
|---|
Most frequent device types declared: SM-01, SM-02, SM-03, SM-05, SM-06.
Devices declared under this manufacturer
- Czarny stabilizator na plecy
- Orteza na kolano
- Orteza na kostkę SM2
- Orteza na łokieć SM03
- Pas lędźwiowy SM01
- Pas lędźwiowy stabilizacyjny
- Sprzęt rehabilitacyjny lędźwiowy
- Stabilizator na palec
- Stabilizator na plecy
Showing 12 of 26 declared devices.
Catalogue references include SM-03, SM-05, SM-06, SM-07, SM-08, SM-09.
European nomenclature codes declared: Y060308, Y060315, Y060603, Y061209, Y060615, Y06120601.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 26 |
| 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 | 26 |
|---|---|
| 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. SILVERMARK SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.