← Back to catalogue
EEG / EOG Kombi Electrode
EUDAMEDClass IIa (EU MDR)
Ref SEP622Model EEG/EOG sensor
Identity
- Trade Name
- EEG / EOG Kombi Electrode EUDAMED
- Model / Reference
- EEG/EOG sensor EUDAMEDSEP622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413400591 EUDAMED
- Basic UDI-DI
- 42504134EEG/EOGZF EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES 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
EEG / EOG Kombi Electrode 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 | 42504134EEG/EOGZF | 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 dc25ba72-5029-4304-8ca5-38872e4e4123 61 fields · synced Jul 18, 2026