Walker
by Zhongshan First Medical Equipment Co., Ltd 7 variants
Ref FST8303AModel FST8201、FST8202、FST8203、FST8204、FST8205、FST8206、FST8207、FST8209、FST8212、FST8230、FST8300、FST8301、FST8302、FST8303、FST8307、FST816H、FST816L、FST815、FST8213、FST8214、FST8215、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 | Number697584560FST003S4 06975845600958 | Date18 Feb 2025 | 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- Withdrawn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
- Model / Reference
- FST8201、FST8202、FST8203、FST8204、FST8205、FST8206、FST8207、FST8209、FST8212、FST8230、FST8300、FST8301、FST8302、FST8303、FST8307、FST816H、FST816L、FST815、FST8213、FST8214、FST8215、etc, FST8303A
- Primary DI / UDI-DI
- 06975845600958
- Basic UDI-DI
- 697584560FST003S4
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044385
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhongshan First Medical Equipment Co., Ltd
See all devices from Zhongshan First 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