Rollator
by Zhongshan First Medical Equipment Co., Ltd 2 variants
Ref FST935, FST9102Model FST9102、FST9103、FST9105、FST9106、FST9182、FST9183、FST9184、FST9185、FST9186、FST9187、FST9188、FST9189、FST9225、FST935A or customized
Rollator (FST935) is a medical device (EU MDR Class I; EMDN category wheeled walker) made by Zhongshan First Medical Equipment Co., Ltd, registered in EUDAMED on 18 Feb 2025 (Basic UDI-DI 697584560FST004S6), active as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697584560FST004S6 | Date18 Feb 2025 | StatusActive |
Official records
- EUDAMED public site 697584560FST004S6
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- Withdrawn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
- FST9102、FST9103、FST9105、FST9106、FST9182、FST9183、FST9184、FST9185、FST9186、FST9187、FST9188、FST9189、FST9225、FST935A or customized, FST935, FST9102
- Primary DI / UDI-DI
- 06975845601146, 06975845601016
- Basic UDI-DI
- 697584560FST004S6
- EMDN code
- Y120606 Wheeled walker
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044385
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Similar devices in this category
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