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Non-invasive EEG electrodes
EUDAMEDClass I (EU MDR)
Ref AMD-DE-AF0004-1Model AMD-DE
Identity
- Trade Name
- Non-invasive EEG electrodes EUDAMED
- Device Name
- Non-invasive EEG electrodes EUDAMED
- Model / Reference
- AMD-DE EUDAMEDAMD-DE-AF0004-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931377228206 EUDAMED
- Basic UDI-DI
- 69313772805US EUDAMED
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Non-invasive EEG electrodes by Shenzhen Amydi-med Electrics Tech Co., Ltd — 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 | 69313772805US | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Amydi-med Electrics Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000013201
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED e3078261-6641-4315-aa6a-9ce48c60b3b8 61 fields · synced Oct 7, 2026