Walker, Rollator
by Zhongshan Qunn Medical Equipment Co., Ltd
Ref ARA88E1, ARA88E2, ARA18E1Model AWLASA0 ,AWLADA0,AWLASJ0,AWLADJ0,AWLASD0,AWLADD0,ARA66E1 ,ARA88E1,ARA18E1,ARA66E2,ARA88E2,ARA18E2,ARS66E1,ARS88E1,ARA18M1,ARA88M1,ARA18H1,ARA88H1
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 | Number697529201CBWALKER6S | Date30 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- Withdrawn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
- Walker, Rollator
- Model / Reference
- AWLASA0 ,AWLADA0,AWLASJ0,AWLADJ0,AWLASD0,AWLADD0,ARA66E1 ,ARA88E1,ARA18E1,ARA66E2,ARA88E2,ARA18E2,ARS66E1,ARS88E1,ARA18M1,ARA88M1,ARA18H1,ARA88H1, ARA88E1, ARA88E2, ARA18E1
- Primary DI / UDI-DI
- 06975292010072, 06975292010102, 06975292010089
- Basic UDI-DI
- 697529201CBWALKER6S
- EMDN Code
- Y120609 Walking frames with chair, 4 wheels
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000017634
- 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