← Back to catalogue
Sensor for determination of the electrodermal activity (EDA)
EUDAMEDClass IIa (EU MDR)
Ref SEW160Model EDA sensor
Identity
- Trade Name
- Sensor for determination of the electrodermal activity (EDA) EUDAMED
- Model / Reference
- EDA sensor EUDAMEDSEW160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413405572 EUDAMED
- Basic UDI-DI
- 42504134edaXA 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
Sensor for determination of the electrodermal activity (EDA) 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 | 42504134edaXA | 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 da2a2ec8-e905-4dd1-8bf5-240c7f52367e 61 fields · synced Jun 19, 2026