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Somfit System
EUDAMEDClass IIa (EU MDR)
Ref 9037-0012-00Model Somfit System Europe (7 electrodes)
Identity
- Device Name
- Somfit System EUDAMED
- Model / Reference
- Somfit System Europe (7 electrodes) EUDAMED9037-0012-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342451002853 EUDAMED
- Basic UDI-DI
- B-09342451002853 EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Somfit System by Compumedics Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09342451002853 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Compumedics Limited
- EUDAMED SRN
- AU-MF-000050437
- Authorised Representative
- Compumedics EUROPE GmbH DE-AR-000039096
Sources (1)
- EUDAMED 76a4d727-1fab-4d9b-9e18-a8fd0f90b608 61 fields · synced Jun 18, 2026