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EEG-Electrode
EUDAMEDClass I (EU MDR)
Ref SEN007/25Model ElectrodesRef SEN007/N/25Ref SEN007/NRef SEN007/5
Identity
- Trade Name
- EEG-Electrode EUDAMED
- Model / Reference
- Electrodes EUDAMEDSEN007/25 EUDAMEDSEN007/N/25 EUDAMEDSEN007/N EUDAMEDSEN007/5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413403288 EUDAMED04250413403295 EUDAMED04250413407217 EUDAMED04250413403271 EUDAMED
- Basic UDI-DI
- 42504134HST-AgBE EUDAMED42504134NG-Ag8X EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMEDZ12100385 ELECTROENCEPHALOGRAPHY 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
Category: General-purpose multi-parameter bedside monitor
EEG-Electrode by SOMNOmedics AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 42504134HST-AgBE | Class I | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (4)
- EUDAMED 62e6d16c-9b4e-4ae7-a3ec-fdb9396430ea 61 fields · synced Aug 3, 2026
- EUDAMED 8738e570-b624-432e-8b04-157c186e7fd7 61 fields · synced May 17, 2026
- EUDAMED 245c7255-9f1c-479c-b0dd-3382ca4875a0 61 fields · synced May 18, 2026
- EUDAMED 54cc836c-a0f1-4680-b085-f8792d7b6721 61 fields · synced May 19, 2026