Spółdzielnia Niewidomych "SINPO"
PL-MF-000004331 · Poland · Poznań
Spółdzielnia Niewidomych "SINPO" is registered in the European database on medical devices as a manufacturer, with 132 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 132 |
|---|
Most frequent device types declared: Amifil M 2MO 502 5-0 CE-3, Amifil M 2MO 504PK 5-0 CE-3F, Amifil M 2MC 304 3-0 CE-7, Amifil M 2MC 302PK 3-0 CE-7F, Amifil M 2MA 604PK 6-0 CE-4F.
Among these devices, 131 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 132 |
| Country of registration | Poland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.