Rollator
by AndCare(Guangdong)Intelligent Technology Co., Ltd. EUDAMED
Active
Ref AC890Model AC890,AC891L,AC8861T,AC8863L,AC8863L2,AC8761L,AC8761L2,AC861,AC862,AC881L,AC882L,AC8864L,AC8860L,AC8861L,AC8862L,AC861L,AC871L,
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697832295R001LA | 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- Withdrawn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
- Rollator
- Model / Reference
- AC890, AC891L, AC8861T, AC8863L, AC8863L2, AC8761L, AC8761L2, AC861, AC862, AC881L, AC882L, AC8864L, AC8860L, AC8861L, AC8862L, AC861L, AC871L
- Primary DI / UDI-DI
- 06978322950546
- Basic UDI-DI
- 697832295R001LA
- 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