Biohit Oyj
FI-MF-000014642 · Finland · Helsinki
Biohit Oyj is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| other | 41 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: HIT-92A.
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 | BIOHIT OYJ (FI) · FDA 9681721 |
| Devices in EUDAMED | 43 |
| Country of registration | Finland |