Walking aids
by AndCare(Guangdong)Intelligent Technology Co., Ltd. EUDAMED
Active
Ref AC821LGModel AC821LG,AC811L,AC812L,AC812L5,AC812LG4,AC821L,AC829L,AC829L1,AC8211L,AC816L,AC816L5,AC816L15,AC816L2,AC816LG3,AC8242L
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697832295WA001LV | Date8 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Walking aids
- Model / Reference
- AC821LG, AC811L, AC812L, AC812L5, AC812LG4, AC821L, AC829L, AC829L1, AC8211L, AC816L, AC816L5, AC816L15, AC816L2, AC816LG3, AC8242L
- Primary DI / UDI-DI
- 06978322950713
- Basic UDI-DI
- 697832295WA001LV
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000053011
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from AndCare(Guangdong)Intelligent 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