Dynamic and Static Balance Evaluation and Training System
by Shandong Zepu Medical Technology Co., Ltd 2 variants
Ref ZEPU-AI10Model ZEPU-AI10 ZEPU-AI10plus
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697663257DASBEATSCB 06976632570416 | Date14 Mar 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dynamic and Static Balance Evaluation and Training System
- Model / Reference
- ZEPU-AI10 ZEPU-AI10plus, ZEPU-AI10
- Primary DI / UDI-DI
- 06976632570416
- Basic UDI-DI
- 697663257DASBEATSCB
- EMDN Code
- Y0504 Arms, torso and legs re-education devices
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037255
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shandong Zepu Medical Technology Co., Ltd
See all devices from Shandong Zepu 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