Rollator
by Wuxi Kangqiang Industrial Equipment Co., Ltd. 5 variants
Ref KQ1015, KQ1128, KQ-1019, KQ1016, KQ1012, KQ-1130, KQ1018Model KQ-1010,KQ-1012,KQ- 1014,KQ-1015,KQ- 1016,KQ-1017,KQ-1018, KQ-1019,KQ-1128,KQ- 1129,KQ-1130,KQ-1131
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 | Number697632593RollatorDZ | Date11 May 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- Withdrawn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
- Rollator
- Model / Reference
- KQ-1010, KQ-1012, KQ- 1014, KQ-1015, KQ- 1016, KQ-1017, KQ-1018, KQ-1019, KQ-1128, KQ- 1129, KQ-1130, KQ-1131, KQ1015, KQ1128, KQ1016, KQ1012, KQ1018
- Primary DI / UDI-DI
- 06976325930039, 06976325930084, 06976325930077, 06976325930046, 06976325930015, 06976325930107, 06976325930060
- Basic UDI-DI
- 697632593RollatorDZ
- EMDN Code
- Y120612, Y120609
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000008695
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wuxi Kangqiang Industrial 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