DUDEK INNOVATIONS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000037588 · Poland · Gdańsk
DUDEK INNOVATIONS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: ENTcover, ENTviewer.
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- B
- BN
- C
- ENTviewer N
- L
- LP
- LPS
- LS
- O
Catalogue references include 05905991498001, 05905991498018, 05905991498025, 05905991498032, 05905991498049, 05905991498063.
European nomenclature codes declared: Z12021004, Z12021080, Z12021009, Z12021085, Z12021006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| 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 | 9 |
|---|---|
| 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. DUDEK INNOVATIONS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.