BIOMEC SRL
IT-MF-000021622 · Italy · COLICO (LC)
BIOMEC SRL is registered in the European database on medical devices as a manufacturer, with 312 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 220 |
|---|---|
| Class IIa | 92 |
Most frequent device types declared: IMPIANTO DENTALE, COMPONENTISTICA PROTESICA IMPIANTABILE IN TITANIO, ACCESSORI PER IMPLANTOLOGIA DENTALE - FASE PROTESICA, ACCESSORI PER IMPLANTOLOGIA DENTALE - STRUMENTAZIONE, DISPOSITIVI PER OSTEOSINTESI.
Among these devices, 125 are declared sterile, 220 implantable, 93 with a measuring function.
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 | 312 |
| Country of registration | Italy |
⚠️ 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.