Opharm S.A.
PL-MF-000011509 · Poland · Pokrzywnica
Opharm S.A. 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: OPM03, SANI-DM-01.
Devices declared under this manufacturer
- OPHARM
- Opharm Podkłady higienicze
Showing 12 of 26 declared devices.
Catalogue references include SANI-DM-01, SANI-DM-03, SANI-DM-04, SANI-DM-06, SANI-DM-07, SANI-DM-09.
European nomenclature codes declared: T020604, T04010201.
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. Opharm S.A. was not found in either the U.S. or the Canadian register.