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Disposable EEG Cap
EUDAMEDClass I (EU MDR)
Ref BM-FC01-23STModel Flex-CapRef BM-FN01-14STRef BM-FA01-23ST
Identity
- Device Name
- Disposable EEG Cap EUDAMED
- Model / Reference
- Flex-Cap EUDAMEDBM-FC01-23ST EUDAMEDBM-FN01-14ST EUDAMEDBM-FA01-23ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970295341826 EUDAMED06970295341833 EUDAMED06970295341819 EUDAMED
- Basic UDI-DI
- 697029534DisCap8G EUDAMED
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Disposable EEG Cap by Wuhan Greentek Pty 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 | 697029534DisCap8G | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Greentek Pty Ltd.
- EUDAMED SRN
- CN-MF-000010400
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED 4ed18179-c5ff-4fd3-8c53-3eead9bf36d7 61 fields · synced Jul 15, 2026
- EUDAMED 29e36f2a-8446-4e93-88b8-d8e776df1b09 61 fields · synced May 17, 2026
- EUDAMED 39bd94ee-ecd1-497d-bfd9-81ad62c3e79e 61 fields · synced May 17, 2026