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OtwoFellow size XL incl. smartphone and app
EUDAMEDClass IIa (EU MDR)
Ref CIR114Model HomeSleepTest
Identity
- Trade Name
- OtwoFellow size XL incl. smartphone and app EUDAMED
- Model / Reference
- HomeSleepTest EUDAMEDCIR114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406579 EUDAMED
- Basic UDI-DI
- 42504134HomeSleepTestYC EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The HomeSleepTest is a portable, miniaturized multi-channel data acquisition and real time therapy system for recording of physiological signals and influencing sleep in the hospital or home environment. The HomeSleepTest assists the physician in the diagnosis and treatment of sleep, mental and neurological disorders. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
OtwoFellow size XL incl. smartphone and app by SOMNOmedics AG — 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 | 42504134HomeSleepTestYC | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED fb8fc872-56a4-48c3-ac59-10f8e08ab9f3 61 fields · synced Jun 18, 2026