Xiangyu Medical
by Sunnyou Medical Co., Ltd. EUDAMED
Active
Ref XY-ZBD-IIEModel XY-ZBD-IC, XY-ZBD-ID, XY-ZBD-IID, XY-ZBD-IIE, XY-ZBD-IIID
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- Withdrawn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
- Passive and Active Exerciser
- Model / Reference
- XY-ZBD-IC, XY-ZBD-ID, XY-ZBD-IID, XY-ZBD-IIE, XY-ZBD-IIID
- Primary DI / UDI-DI
- 06970291640947
- Basic UDI-DI
- 697029164XY-ZBDUC
- Direct Marketing DI
- 06970291640947
- EMDN Code
- Z12069002 Assisted locomotion systems
- Device Class
- Class IIa
- Market of Registration
- Ireland
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