Identity
- Trade Name
- Bittium Respiro EUDAMED
- Device Name
- Sleep devices EUDAMED
- Model / Reference
- 9404612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035220540 EUDAMED
- Basic UDI-DI
- 643003522SleepDisordersT7 EUDAMED
- Direct Marketing DI
- 06430035220540 EUDAMED
- EMDN Code
- Z129012 MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bittium Respiro 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 | 643003522SleepDisordersT7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bittium Biosignals Oy
- EUDAMED SRN
- FI-MF-000013983
Sources (1)
- EUDAMED 037a57b6-0691-4268-b93c-4b49edebfee3 61 fields · synced Jun 18, 2026