Identity
- Trade Name
- EEG-sensor EUDAMEDEEG sensor EUDAMED
- Model / Reference
- EEG-Headbox EUDAMEDSEW141 EUDAMEDSEW140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413405633 EUDAMED04250413405626 EUDAMED
- Basic UDI-DI
- 42504134EEG-S6L EUDAMED
- EMDN Code
- Z12100380 ELECTROENCEPHALOGRAPHY INSTRUMENTS - 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-sensor 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-S6L | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 136feda6-aab2-48bf-8054-040b79a40e84 61 fields · synced Jul 22, 2026
- EUDAMED d740384e-d546-45c0-a441-6b1088e15319 61 fields · synced May 17, 2026