Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBittium Biosignals , Ltd.
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Me6000 | ME6000 8ch WLAN | FDA UDI | Class II | Unknown |
| Me6000 | ME6000 8ch | FDA UDI | Class II | Unknown |
| FemiScan | Cover | FDA UDI | Class II | Unknown |
| Me6000 | ME6000 4ch | FDA UDI | Class II | Unknown |
| Faros | Faros 360 | FDA UDI | Class II | Active |
| Me6000 | ME6000 16ch | FDA UDI | Class II | Unknown |
| Faros | Faros 90 | FDA UDI | Class II | Active |
| FemiScan | HTCS-2 | FDA UDI | Class II | Unknown |
| Bittium Faros | Faros 14d | FDA UDI | Class II | Active |
| Faros 360 waterproof | Faros 360 | FDA UDI | Class II | Active |
| Faros | Faros 180 | FDA UDI | Class II | Active |
| Me6000 | ME6000 4ch WLAN | FDA UDI | Class II | Unknown |
| Bittium Faros 180 waterproof | Faros 180 | FDA UDI | Class II | Active |
| Fast-Fix ECG Electrode | 901155 | FDA UDI | Class II | Active |
| eMotion ECG | eMotion ECG sensor | FDA UDI | Class II | Unknown |
| Faros Mobile | K182030 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bittium Biosignals Ltd FI