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Somfit System
EUDAMEDClass IIa (EU MDR)
Ref 9037-0002-00Model Somfit System EuropeRef 9037-0002-02Model SomfitRef 8037-0001-00 Ref 8037-0102-01 Ref 8037-0002-01
Identity
- Device Name
- Somfit System EUDAMED
- Model / Reference
- Somfit System Europe EUDAMED9037-0002-00 EUDAMEDSomfit EUDAMED9037-0002-02 EUDAMED8037-0001-00 EUDAMED8037-0102-01 EUDAMED8037-0002-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342451002761 EUDAMED09342451007308 EUDAMED09342451002655 EUDAMED09342451006011 EUDAMED09342451006004 EUDAMED
- Basic UDI-DI
- B-09342451002761 EUDAMED9342451SomfitTU EUDAMED
- Direct Marketing DI
- 09342451007308 EUDAMED09342451006011 EUDAMED09342451006004 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
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
Somfit System by Compumedics Limited — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-09342451002761 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-09342451002761 | 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 (5)
- EUDAMED 77f799b6-c466-420c-ac3a-9875e598d594 61 fields · synced Aug 4, 2026
- EUDAMED 735dc607-3d95-4a03-900d-d34f13945e45 61 fields · synced Jul 9, 2026
- EUDAMED eb113f4d-79ab-4d55-aaa9-98a4dfcb9f2c 61 fields · synced Jul 14, 2026
- EUDAMED b90fb57c-9a98-4616-b50c-70d6e6d23455 61 fields · synced Jul 26, 2026
- EUDAMED c21970be-48d6-4551-ac2c-da961a1516dd 61 fields · synced Aug 4, 2026