Roberta
by Health and Fashion Shoes Italia SpA 32 variants
Ref F325251008380, F325251008410, F325251008350, F325251004360, F325251008420, F325251004380, F325251008390, F325251004390
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 | Number805714973REMOVINSOLEWH | Date27 May 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- Withdrawn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
- Scholl Removable Insole Bioprint Shoes
- Model / Reference
- F325251008380, F325251008410, F325251008350, F325251004360, F325251008420, F325251004380, F325251008390, F325251004390
- Primary DI / UDI-DI
- 08004373635762, 08004373635793, 08004373635731, 08004373635663, 08004373635809, 08004373635687, 08004373635779, 08004373635694
- Basic UDI-DI
- 805714973REMOVINSOLEWH
- EMDN Code
- Y061203, Y063303
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000038685
Other devices from Health and Fashion Shoes Italia SpA
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No