Identity
- Trade Name
- Bittium Respiro Analyst EUDAMED
- Device Name
- Sleep apnea test analysis software EUDAMED
- Model / Reference
- 9530488 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035220762 EUDAMED
- Basic UDI-DI
- 643003522SleepAnalysisFC EUDAMED
- Direct Marketing DI
- 06430035220762 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bittium Respiro Analyst 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 | 643003522SleepAnalysisFC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (1)
- EUDAMED ed54e766-ed2f-4820-bb2b-7f56628d5499 61 fields · synced Jun 18, 2026