"Biovico" Spółka z ograniczoną odpowiedzialnością
PL-MF-000010559 · Poland · Gdynia
"Biovico" Spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 14 |
|---|---|
| Class IIa | 6 |
Most frequent device types declared: Flavya™ Post Treatment Occlusive Face Mask, Flavya™ Medium .
Among these devices, 14 are declared sterile, 14 implantable.
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 | 20 |
| 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 |
|---|---|---|
1434-MDR-040/2025 | amended | 2030-12-15 |
1434-MDR-039/2025 | issued | 2030-12-15 |
1434-MDR-038/2025 | issued | 2030-12-15 |
1434-MDR-037/2025 | issued | 2030-12-15 |
1434-MDR-036/2025 | issued | 2030-12-15 |
1434-MDR-035/2025 | issued | 2030-12-15 |
1434-MDR-034/2025 | issued | 2030-12-15 |
1434-MDR-033/2025 | issued | 2030-12-15 |