Xiangyu Medical
by Sunnyou Medical Co., Ltd. EUDAMED
Active
Ref XYKXZFK-9
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN25/00000057 | Date6 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CN25/00000057 Amended
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 6 May 2026
- Expires
- 3 Jan 2030
- Reason
- Mnf data change
Specification
- Device Name
- Lower Limb Rehabilitation System
- Model / Reference
- XYKXZFK-9
- Primary DI / UDI-DI
- 06970291640725
- Basic UDI-DI
- 697029164XYKXZFK-9PH
- Direct Marketing DI
- 06970291640725
- EMDN Code
- Z12069002 Assisted locomotion systems
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000001112
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Sunnyou Medical Co., Ltd.
Properties
Show 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