Sophia
by Podowell EUDAMED
Active
Ref SOPHIA-7060-P41Model SOPHIA
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number337612AAAAAAAAAAAAAAAERNP | Date18 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Sophia
- Model / Reference
- SOPHIA, SOPHIA-7060-P41
- Primary DI / UDI-DI
- 03376122366155
- Basic UDI-DI
- 337612AAAAAAAAAAAAAAAERNP
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000001191
Other devices from Podowell
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