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Sleep Adagio® PSG pro
EUDAMEDClass IIa (EU MDR)
Ref SAW050Model Sleep AdagioRef SAD253
Identity
- Trade Name
- Sleep Adagio® PSG pro EUDAMEDSleep Adagio PSG PRO EUDAMED
- Model / Reference
- Sleep Adagio EUDAMEDSAW050 EUDAMEDSAD253 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413403868 EUDAMED04250413407118 EUDAMED
- Basic UDI-DI
- 42504134SleepA36 EUDAMED42504134SleepAdagioDD EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
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
Sleep Adagio® PSG pro 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 | 42504134SleepA36 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED e718c48e-71e7-472e-8920-c6fbed716cb7 61 fields · synced Jul 27, 2026
- EUDAMED 71dadc78-f1c5-4aa5-81a5-a4fa065f8222 61 fields · synced Jul 27, 2026