Identity
- Trade Name
- BIO Neuro Sensor EUDAMED
- Device Name
- EEG SENSOR EUDAMED
- Model / Reference
- BME-2003 EUDAMEDSC02 EUDAMEDBME-2002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809233902035 EUDAMED08809233902028 EUDAMED
- Basic UDI-DI
- B-08809233902035 EUDAMEDB-08809233902028 EUDAMED
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BIO Neuro Sensor by Bio Medical Technologies Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809233902035 | Class I | Active |
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Manufacturer
- Manufacturer
- Bio Medical Technologies Co., Ltd.
- EUDAMED SRN
- KR-MF-000009711
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED dc75b53b-c17b-4c17-97ce-1cae6e31457a 61 fields · synced Aug 2, 2026
- EUDAMED 2cb505d0-2d2e-4cf7-9656-692055bb5f4a 61 fields · synced May 16, 2026