"Biofaktor" Sp. z o. o.
PL-MF-000027226 · Poland · Gorzów Wielkopolski
"Biofaktor" Sp. z o. o. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|---|
| Class IIb | 4 |
Most frequent device types declared: Vaginal globules , Nasal spray, Rectal suppositories , Vaginal globules.
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 | 9 |
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023871-1 | supplemented | 2031-02-05 |