Identity
- Trade Name
- Bittium Respiro HSAT EUDAMEDBittium Respiro HSAT System EUDAMED
- Device Name
- Bittium Respiro HSAT EUDAMEDBittium Respiro HSAT system EUDAMED
- Model / Reference
- 9404610 EUDAMEDS0000021617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035221066 EUDAMED06430035221059 EUDAMED
- Basic UDI-DI
- 643003522RespiroHSATPPH6 EUDAMED643003522RespiroHSATSPPGQ EUDAMED
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The device is intended to be used as an ambulatory recording device for overnight polygraphy, which is always carried out by doctor's prescription. EUDAMEDThe device is intended to be used as an ambulatory recording device for overnight polygraphy, which is always carried out by doctor’s prescription. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Bittium Respiro HSAT by Bittium Biosignals Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643003522RespiroHSATPPH6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-PR-000045558
Sources (2)
- EUDAMED 7443b56c-119a-4d7e-bd3a-1f9073276207 61 fields · synced Jul 17, 2026
- EUDAMED b282d1ac-02f5-4581-adbc-45aa659ed316 61 fields · synced May 18, 2026