← Back to catalogue
Sleep Adagio PSG small Headbox & PLM
EUDAMEDClass IIa (EU MDR)
Ref SAD210Model Sleep Adagio
Identity
- Trade Name
- Sleep Adagio PSG small Headbox & PLM EUDAMED
- Model / Reference
- Sleep Adagio EUDAMEDSAD210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406999 EUDAMED
- Basic UDI-DI
- 42504134SleepAdagioDD EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The Sleep Adagio® is a portable device for recording physiological signals, which serves the physician as a polygraphy (PG) or Polysomnography (PSG) system to assist in the diagnosis of sleep disorders. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Sleep Adagio PSG small Headbox & PLM 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 | 42504134SleepAdagioDD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED 8641d04a-a7bb-4b9a-8685-6ffa8a1b2f99 61 fields · synced Jul 15, 2026