Oticon Medical AB
SE-MF-000000724 · Sweden · Askim
Oticon Medical AB is registered in the European database on medical devices as a manufacturer, with 133 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 133 |
|---|
Among these devices, 8 are declared sterile, 9 reusable, 21 active, 1 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 | Registered with FDA |
|---|---|
| Matched entry | Oticon Medical AB (SE) · FDA 3007367732 |
| Devices in EUDAMED | 133 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 106872 0003 | issued | 2026-07-18 |