Ortoma AB
SE-MF-000034945 · Sweden · Gothenburg
Ortoma AB is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|---|
| Class IIb | 1 |
Among these devices, 4 are declared sterile, 16 reusable, 5 active, 2 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 | ORTOMA AB (SE) · FDA 3014411622 |
| Devices in EUDAMED | 25 |
| Country of registration | Sweden |