knee walker
by Foshan Highway Medical Equipment Co. Ltd 10 variants
Ref 8010Model 8001,8002,8003,8004,8005,8006, 8007,8008,8009,8010,8011,8012, 8013,8014,8015
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6974853678007GX 06974853678102 | Date6 Oct 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- knee walker
- Model / Reference
- 8001, 8002, 8003, 8004, 8005, 8006, 8007, 8008, 8009, 8010, 8011, 8012, 8013, 8014, 8015
- Primary DI / UDI-DI
- 06974853678102
- Basic UDI-DI
- 6974853678007GX
- EMDN Code
- Y120612 Walking trolleys
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000003238
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Foshan Highway Medical Equipment Co. Ltd
See all devices from Foshan Highway Medical Equipment 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