Medical Image Processing Software
by YIWEI Medical Technology Co., Ltd EUDAMED
Active
Ref DrBrain-SWIModel DrBrain、TIHip、DrBrain-WMH、DrBrain-SWI、DrBrain-AGE
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697478241DrBrainUT | Date17 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- DrBrain、TIHip、DrBrain-WMH、DrBrain-SWI、DrBrain-AGE, DrBrain-SWI
- Primary DI / UDI-DI
- 06974782410316
- Basic UDI-DI
- 697478241DrBrainUT
- Direct Marketing DI
- 06974782410316
- EMDN Code
- Z12069099 Various physiotherapy and rehabilitation instruments - other
- Device Class
- Class I
- Special Device Type
- Software
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000057694
- Authorised representative
- Crealkraft GmbH DE-AR-000049943
Other devices from YIWEI Medical Technology Co., Ltd
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