← Back to catalogue
AASM headbox for Sleep Adagio
EUDAMEDClass IIa (EU MDR)
Ref SAS095Model EEG-Headbox
Identity
- Trade Name
- AASM headbox for Sleep Adagio EUDAMED
- Model / Reference
- EEG-Headbox EUDAMEDSAS095 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413403936 EUDAMED
- Basic UDI-DI
- 42504134H-BMB EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER 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
AASM headbox 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 | 42504134H-BMB | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED d3946342-aff0-488c-ab01-cd9d0168d762 61 fields · synced Jun 17, 2026