Bunion Corrector
by Shijiazhuang aofeite imp&exp co., ltd 16 variants
Ref EPS2Model Flexifeet: Bunion Corrector ZSNT, ZSNB, ZSNW, ZSNG, ZSRT, ZSRB, ZSRW; Active Toe Spreader ZSAT, ZSAB, ZSAW, ZSAWB; Bunion Corrector Splint ZSS1, ZSS2; Heel Cushion Pads FEPO4-SM,FEPO4-LXL, FEPO6; Heel Protectors FESU4, FESU6.
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 | Number697852731FO001J3 | Date29 Apr 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- Withdrawn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
- Flexifeet Orthotics
- Model / Reference
- Flexifeet: Bunion Corrector ZSNT, ZSNB, ZSNW, ZSNG, ZSRT, ZSRB, ZSRW, Active Toe Spreader ZSAT, ZSAB, ZSAW, ZSAWB, Bunion Corrector Splint ZSS1, ZSS2, Heel Cushion Pads FEPO4-SM, FEPO4-LXL, FEPO6, Heel Protectors FESU4, FESU6., EPS2
- Primary DI / UDI-DI
- 06953751901222, 06953751996327
- Basic UDI-DI
- 697852731FO001J3, 69537519BUNION2C
- EMDN Code
- Y06120601, Y061203
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000011825
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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