Dynamic And Static Balance Evaluation And Training System
by MediRobotic technology Co., Ltd. EUDAMED
Active
Ref ZEPU-AI10Model ZEPU-AI10,ZEPU-AI10plus
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697774623CE008H9 | Date29 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dynamic And Static Balance Evaluation And Training System
- Model / Reference
- ZEPU-AI10, ZEPU-AI10plus
- Primary DI / UDI-DI
- 06977746230210
- Basic UDI-DI
- 697774623CE008H9
- EMDN Code
- Z120603 Passive rehabilitative gymnastics equipment
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042421
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from MediRobotic 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