Biological Feedback and Stimulation System
by Medlander Medical Technology Inc. China EUDAMED
Ref MLD B4PlusModel MLD B4A, MLD B4D, MLD B4T, MLD B4Plus，MLD M4A, MLD M4D, MLD M4R, MLD M4Plus
EMDN Z12062401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697061609BioStim65014Z9 | Date8 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 6131346CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 7 Sep 2026
- Expires
- 1 Feb 2031
- Reason
- Add device or group
Specification
- Device Name
- Biological Feedback and Stimulation System
- Model / Reference
- MLD B4A, MLD B4D, MLD B4T, MLD B4Plus，MLD M4A, MLD M4D, MLD M4R, MLD M4Plus, MLD B4Plus
- Primary DI / UDI-DI
- 06970616090082
- Basic UDI-DI
- 697061609BioStim65014Z9
- Direct Marketing DI
- 06970616090082
- EMDN Code
- Z12062401 Electromyographic biofeedback systems
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000017801
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Medlander Medical Technology Inc.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 06970616090082|697061609BIOSTIM65014Z9