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OtwoFellow size XL incl. cloud account
EUDAMEDClass IIa (EU MDR)
Ref CIR124Model HomeSleepTest
Identity
- Trade Name
- OtwoFellow size XL incl. cloud account EUDAMED
- Model / Reference
- HomeSleepTest EUDAMEDCIR124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413407323 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. cloud account 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 2a9ee8b0-9c6a-459b-b7c8-98071c5f1c70 61 fields · synced Jun 20, 2026