EEG Electrode
by Shenzhen Med-link Electronics Tech Co., Ltd. 46 variants
Ref B143-N-YEL-60Model B134-N-BLA-60
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69444140003SJ 06944414028776 | Date29 Apr 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- B134-N-BLA-60, B143-N-YEL-60
- Primary DI / UDI-DI
- 06944414028776
- Basic UDI-DI
- 69444140003SJ
- EMDN Code
- N01010202 EEG extracranic electrodes
- Device Class
- Class I
- EU 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: EEG/EMG Lead Wires With Electrodes
Other devices from Shenzhen Med-Link Electronics Tech Co., Ltd.
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Properties
Other properties (12)
- 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