FB VISION S.p.A.
IT-MF-000020083 · Italy · San Benedetto del Tronto
FB VISION S.p.A. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 24 |
|---|
Most frequent device types declared: LUMIXA, OZODROP, LACRICOMPLEX.
Among these devices, 24 are declared sterile, 12 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 | 24 |
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT328004 | issued | 2028-12-19 |
0425-MDR-030111-00 | issued | 2029-12-18 |