Disposable Non-invasive EEG Sensor
by Shenzhen Med-link Electronics Tech Co., Ltd. EUDAMED
Active
Ref B-BIS-3AModel B-BIS-4A
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69444140004SL | Date29 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- B-BIS-4A, B-BIS-3A
- Primary DI / UDI-DI
- 06944414089906, 06944414083027, 06944414088855, 06944414078757, 06944414081351, 06944414081306, 06944414082884, 06944414072281, 06944414040082, 06944414045544, 06944414077255, 06944414080507
- Basic UDI-DI
- 69444140004SL
- EMDN Code
- N01010202 EEG extracranic electrodes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011145
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
From the manufacturer
Manufacturer's product page: Disposable EEG Sensor
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No