Walking Aids, Rollator
by Guangzhou Topmedi Co., Ltd. 31 variants
Ref TWA009Model TWA9127L,TWA004,TWA009,THE965L,TWA965LH,TWA965LH-1,TWA965LH-A,THE965LF1,TWA9650LH,TWA965LH-B,TWA965LHF1,TWA966LH,TWA966LH-B, etc
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 | Number697438762TWA001UZ 06974387622336 | Date13 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- Withdrawn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
- Model / Reference
- TWA9127L, TWA004, TWA009, THE965L, TWA965LH, TWA965LH-1, TWA965LH-A, THE965LF1, TWA9650LH, TWA965LH-B, TWA965LHF1, TWA966LH, TWA966LH-B, etc
- Primary DI / UDI-DI
- 06974387622336
- Basic UDI-DI
- 697438762TWA001UZ
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000016883
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Guangzhou Topmedi 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