Rollator
by Maidecare Group Limited EUDAMED
Active
Ref A01Model A01、A02、A03、A05、A06、A07、A08、A09、A11、A12、A15、A16、A17、A18、A19、A21、A22、A23、A25、A26、A27、A28、A29、A31、A32、A33、A35、A36、A37、A38、A39、A41、A42、A43、A45、A46、A47、A48、A49、A51、A52、etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number489715353R001G6 | Date21 Apr 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- Withdrawn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
- A01、A02、A03、A05、A06、A07、A08、A09、A11、A12、A15、A16、A17、A18、A19、A21、A22、A23、A25、A26、A27、A28、A29、A31、A32、A33、A35、A36、A37、A38、A39、A41、A42、A43、A45、A46、A47、A48、A49、A51、A52、etc, A01
- Primary DI / UDI-DI
- 04897153530012
- Basic UDI-DI
- 489715353R001G6
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- HK-MF-000053230
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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