Rollator
by Yongkang beiqin industry and trade co., ltd 31 variants
Ref 9004Model 1001A,1002B,1003C,1002C,1004D, 1005E,2001A, 2002B, 3001A, 3001B, 3002B, 3003C, 3004D, 3004E, 3004F, 3004G, 3004H, 3005E, 3005F, 4001A, 4001B, 5001A, 5001B, 9004, 801A, 804E, 802B, 803C, 804D,9001, 9002, 9003, 9003B
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 | Number697776233ROL01TY | Date31 Aug 2024 | 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- Withdrawn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
- 1001A, 1002B, 1003C, 1002C, 1004D, 1005E, 2001A, 2002B, 3001A, 3001B, 3002B, 3003C, 3004D, 3004E, 3004F, 3004G, 3004H, 3005E, 3005F, 4001A, 4001B, 5001A, 5001B, 9004, 801A, 804E, 802B, 803C, 804D, 9001, 9002, 9003, 9003B
- Primary DI / UDI-DI
- 06977762330475, 06975052440897
- Basic UDI-DI
- 697776233ROL01TY, 697505244ROL01KW
- EMDN Code
- Y120603 Walking frames, 4 tips
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000033005
- Authorised representative
- REP Europe GmbH DE-AR-000025090
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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