Active and Passive Rehabilitation Trainer
by Guangzhou Fourier Intelligence Co., Ltd. China EUDAMED
Ref 001Model CycleMotus A4 EMDN Z120616
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN25/00001262 | Date4 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CN25/00001262 Issued
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 4 Mar 2025
- Expires
- 4 Mar 2030
Specification
- Device Name
- Active and Passive Rehabilitation Trainer
- Model / Reference
- CycleMotus A4, 001
- Primary DI / UDI-DI
- 06975212280011
- Basic UDI-DI
- 697521228001GY
- Direct Marketing DI
- 06975212280011
- EMDN Code
- Z120616 Electromechanical systems for physical therapy
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000024515
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Guangzhou Fourier Intelligence Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED d3473ff1-cb5d-4634-a857-6d6e7d0e6174