INEOCARE SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000034645 · Poland · Dobroszyce
INEOCARE SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 335 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 335 |
|---|
Devices declared under this manufacturer
- ACCESS PRO M1
- ACCESS PURE M1
- LAUFEN
- PLUS
- PURE
- TRINNITY
Showing 12 of 335 declared devices.
Catalogue references include H3894114400111, H3894124401041, H3894319281501, H3894329280111, LD0.0010.5**, PW0.0004.5**.
European nomenclature codes declared: V0899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 335 |
| 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 | 335 |
|---|---|
| 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. INEOCARE SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.