Identity
- Device Name
- Somfit Electrode with Prep Pad EUDAMED
- Model / Reference
- 7037-1001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342451007148 EUDAMED
- Basic UDI-DI
- 9342451ELECTRODEEH EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Somfit Electrode with Prep Pad by Compumedics Limited — Class I — 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 | 9342451ELECTRODEEH | Class I | 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 bfb59a17-41aa-42b4-bc0a-d08873cd2865 61 fields · synced Jul 8, 2026