Bittium Biosignals Oy
FI-MF-000013983 · Finland · Kuopio
Bittium Biosignals Oy is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 34 |
|---|
Most frequent device types declared: Respiro Accessories, OmegaSnap, 180, MedicalSuite Center v3.x, MedicalSuite Mobile v3.x.
Among these devices, 14 are declared active, 10 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 | Bittium Biosignals Ltd. (FI) · FDA 1000425315 |
| Devices in EUDAMED | 34 |
| Country of registration | Finland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1030-811-22 | supplemented | 2027-06-22 |