Identity
- Trade Name
- SOMNO HD eco RC pediatric EUDAMED
- Model / Reference
- SOMNO HD EUDAMEDNGN100Ap EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406944 EUDAMED
- Basic UDI-DI
- 42504134SOMNOHDND EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The SOMNO HD is a portable device for continuous recording of physiological signals. It can serve the physician as a polysomnography (PSG) system to assist in the diagnosis of sleep disorders, as well as a long-term EEG device. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
SOMNO HD eco RC pediatric 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 | 42504134SOMNOHDND | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED 9dc39cb8-0e81-4ef8-8739-d247f3cd667f 61 fields · synced Jun 18, 2026