"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™ Medium, Flavya™ Post Treatment Occlusive Face Mask.
Among these devices, 14 are declared sterile, 14 implantable.
Devices declared under this manufacturer
- Biolevox™ HA
- Biolevox™ HA one
- Biolevox™ HA tendon
- Biolevox™ mini
- Flavya™ Excellence
- Flavya™ Medium
- Flavya™ Post Treatment Occlusive Face Mask
- Flavya™ Post Treatment Occlusive Patch
- Lipotris
- Lipotris™
- Monoshot™ HA
- Progum™ HA
Showing 12 of 20 declared devices.
Catalogue references include Not applicable, PRO00791, PRO00792, PRO00797, PRO00798, PRO00819.
European nomenclature codes declared: P900402, V9099, Q0199, Q010699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 20 |
| 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 | 20 |
|---|---|
| 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. "Biovico" Spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.
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 |