Bioton S.A.
PL-MF-000030862 · Poland · Warszawa
Bioton S.A. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 6 |
|---|
Most frequent device types declared: PEN.A4.002.16, PEN.A4.003.16, PEN.A4.004.16.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- GensuPen 2
Catalogue references include PEN.A4.002.16, PEN.A4.003.16, PEN.A4.004.16.
European nomenclature codes declared: A020299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. Bioton S.A. was not found in either the U.S. or the Canadian register.