FOTONA, proizvodnja optoelektronskih naprav d.o.o.
SI-MF-000000126 · Slovenia · Ljubljana
FOTONA, proizvodnja optoelektronskih naprav d.o.o. is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 29 |
|---|---|
| Class IIa | 2 |
Among these devices, 31 are declared active.
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 | 31 |
| Country of registration | Slovenia |
⚠️ 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 |
|---|---|---|
G10 025155 0029 | issued | 2027-01-18 |
2022-MDR/QS-021/A | issued | 2027-09-21 |