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Somfit Pro System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 9037-0016-00Model Somfit Pro System EU510(k) K231546Ref 9037-0020-00Model Somfit Respifit Module – Somfit Pro Upgrade Kit
Identity
- Device Name
- Somfit Pro System EUDAMED
- Model / Reference
- Somfit Pro System EU EUDAMED9037-0016-00 EUDAMEDSomfit Respifit Module – Somfit Pro Upgrade Kit EUDAMED9037-0020-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342451006554 EUDAMED09342451006592 EUDAMED
- Basic UDI-DI
- B-09342451006554 EUDAMEDB-09342451006592 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 Pro System by Compumedics Limited — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231546 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-09342451006554 | 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 (3)
- EUDAMED d167276b-8dc5-4312-afea-fc77906a01fa 85 fields · synced Aug 1, 2026
- EUDAMED 0ed8d390-a8c1-4201-b978-36bc7934be05 61 fields · synced May 17, 2026
- FDA 510(k) K231546 1 fields · synced May 18, 2026