Rover
by Health and Fashion Shoes Italia SpA 7 variants
Ref F324923680420, F324921002400, F324921002350, F324923680380, F324921002410, F324921002370, F324923680400, F324921002390, F324923680370, F324923680350
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 | Number805714973BIOMECHANICSW4 | Date26 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- Withdrawn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 Biomechanics Shoes
- Model / Reference
- F324923680420, F324921002400, F324921002350, F324923680380, F324921002410, F324921002370, F324923680400, F324921002390, F324923680370, F324923680350
- Primary DI / UDI-DI
- 08004373646539, 08004373646591, 08004373646546, 08004373646492, 08004373646607, 08004373646560, 08004373646515, 08004373646584, 08004373646485, 08004373646461
- Basic UDI-DI
- 805714973BIOMECHANICSW4
- 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 (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