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Disposable EEG sensor
EUDAMEDClass I (EU MDR)
Ref /Model SE-A11-L、SE-A11-N、SE-A10-N、SE-P11-N、SE-P11-L、SE-P10-L、SE-P10-N、SE-A10-L
Identity
- Trade Name
- Disposable EEG sensor EUDAMED
- Device Name
- Disposable EEG sensor EUDAMED
- Model / Reference
- SE-A11-L、SE-A11-N、SE-A10-N、SE-P11-N、SE-P11-L、SE-P10-L、SE-P10-N、SE-A10-L EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16978789340062 EUDAMED
- Basic UDI-DI
- 697878934102UC EUDAMED
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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 sensor by Braincare (Suzhou) Medical Device 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 | 697878934102UC | Class I | Active |
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Manufacturer
- Manufacturer
- Braincare (Suzhou) Medical Device Co. Ltd.
- EUDAMED SRN
- CN-MF-000051974
- Authorised Representative
- NEO HEALTHIES LIMITED IE-AR-000000905
Sources (1)
- EUDAMED 019c0300-2dfa-4559-9794-7aff8242d2a4 61 fields · synced Jun 18, 2026