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: 14D, 180, 180L, 360, ECG Patient Cable.
Among these devices, 14 are declared active, 10 with a measuring function.
Devices declared under this manufacturer
- Bittium APV20
- Bittium MedicalSuite Center
- Bittium MedicalSuite Mobile
- Bittium Respiro
- Bittium Respiro Analyst
- BrainStatus EEG electrode
- Mini UL
- MiniSnap Sensitive 1-CH ECG Electrode
- OmegaSnap 1-CH ECG Electrode
- OmegaSnap 3-CH ECG Electrode
- OmegaSnap Multi-CH Adapter
- Respiro 1 RIP Belt Patch
Showing 12 of 34 declared devices.
Catalogue references include 9305402, 9404611, 9404612, 9404613, 9404718, 9404719.
European nomenclature codes declared: Z129012, C020501, Z12050403, V0399, V92, Z12050392.
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 |
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 22.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BITTIUM BIOSIGNALS LTD. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2017-04-20 |
Licence types: System (1).
Licensed under: EMOTION FAROS CARDIAC MONITORS.
North American profile: Both markets. Bittium Biosignals Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1030-811-22 | supplemented | 2027-06-22 |