Optomed Oyj
FI-MF-000009407 · Finland · Oulu
Optomed Oyj is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 21 |
|---|
Most frequent device types declared: Smartscope, Aurora, Visuscout 100, Signal, Signal Camera.
Among these devices, 18 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 | Registered with FDA |
|---|---|
| Matched entry | Optomed (FI) · FDA 3007710608 |
| Devices in EUDAMED | 21 |
| Country of registration | Finland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI24/00000061 | supplemented | 2029-06-05 |
FI24/00000061 | reissued | 2030-06-16 |