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 2MA 302 CE-4, Amifil M 2MA 504PK 5-0 CE-4F, Amifil M 2MA 604PK 6-0 CE-4F, Amifil M 2MB 202 2-0 CE-6, Amifil M 2MB 402 4-0 CE-6.
Among these devices, 131 are declared sterile.
Devices declared under this manufacturer
- Amifil M
- Amifli M
- Spółdzielnia Niewidomych SINPO
Showing 12 of 132 declared devices.
Catalogue references include 580315, 580319, 580335, 580452, 580459, 580462.
European nomenclature codes declared: H010201010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 132 |
| 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 | 132 |
|---|---|
| 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. Spółdzielnia Niewidomych "SINPO" was not found in either the U.S. or the Canadian register.