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Soft Silicone Finger Sensor for Sleep Adagio
EUDAMEDClass IIa (EU MDR)
Ref SAS062Model SpO2 sensorRef TOS061
Identity
- Trade Name
- Soft Silicone Finger Sensor for Sleep Adagio EUDAMEDSoft Silicone Finger Sensor EUDAMED
- Model / Reference
- SpO2 sensor EUDAMEDSAS062 EUDAMEDTOS061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413403806 EUDAMED04250413405046 EUDAMED
- Basic UDI-DI
- 42504134FC4Z EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Soft Silicone Finger Sensor for Sleep Adagio 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 | 42504134FC4Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 1e491973-18e4-473c-bfee-c8aefdcf05d7 61 fields · synced Jul 13, 2026
- EUDAMED 84f2b5a1-b8ad-43a9-aa8f-800983eb013f 61 fields · synced May 18, 2026