Rollator Walker
by Shenzhen Zuowei Technology Co., Ltd. 20 variants
Model ZW8318L
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697415392ZW8318LWR 06974153923186 | Date15 Nov 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Rollator Walker
- Model / Reference
- ZW8318L
- Primary DI / UDI-DI
- 06974153923186
- Basic UDI-DI
- 697415392ZW8318LWR
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000022824
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Zuowei Technology Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: 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