Rollator
by Huizhou Yixiang Medical Equipment Co., Ltd. 18 variants
Ref 6317BModel 6213D,6213C,6819,6928-12,6921C,6616B,6226,6012B,6012S,6317A,6317B,6214A,6818,6213,6021A,6921D,6120A,6120C,8022BC,8922,8627-1,8220C,8222,8029KDB,8121B,8121,8326T3,8120,8326C-12,8120B,8321B,8321,8129,8129-1,8128-8,8128-6,8329,8828B-1,8829-6
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 | Number697674743YXROLLATOR4Q 06976747430100 | Date20 Sep 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- Withdrawn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
- 6213D, 6213C, 6819, 6928-12, 6921C, 6616B, 6226, 6012B, 6012S, 6317A, 6317B, 6214A, 6818, 6213, 6021A, 6921D, 6120A, 6120C, 8022BC, 8922, 8627-1, 8220C, 8222, 8029KDB, 8121B, 8121, 8326T3, 8120, 8326C-12, 8120B, 8321B, 8321, 8129, 8129-1, 8128-8, 8128-6, 8329, 8828B-1, 8829-6
- Primary DI / UDI-DI
- 06976747430100
- Basic UDI-DI
- 697674743YXROLLATOR4Q
- EMDN Code
- Y120612 Walking trolleys
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000037508
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Huizhou Yixiang Medical Equipment Co., Ltd.
See all devices from Huizhou Yixiang 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