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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
- 16978789340017 EUDAMED16978789340024 EUDAMED16978789340055 EUDAMED16978789340079 EUDAMED16978789340000 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 (5)
- EUDAMED 130b1b80-795f-4ee7-a151-857bc63b9d19 61 fields · synced Aug 1, 2026
- EUDAMED 59e01d9f-cd19-4348-8eae-64674e1b3cd4 61 fields · synced May 17, 2026
- EUDAMED 4905d4c1-a62f-4c51-9c53-faa0d15eb2ad 61 fields · synced May 19, 2026
- EUDAMED d62c82ac-3169-4ed5-a822-665a9580f177 61 fields · synced May 19, 2026
- EUDAMED dae37c9e-6c90-48a2-ba62-963b00988fc2 61 fields · synced May 19, 2026