Model 1XL Black 39
Part of a family of 126 devices: see the family page
Ref FD0107Model MODEL 1 - MODEL W - MODEL H
Model 1XL Black 39 (FD0107) is a Class I device made by Well Walking S.r.l., registered in EUDAMED on 12 Jun 2024 (Basic UDI-DI 805763974FD0NB), active as of 25 Oct 2026.
Active
CE MDR
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 | Number805763974FD0NB | Date12 Jun 2024 | StatusActive |
Official records
- EUDAMED public site 805763974FD0NB
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- Withdrawn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
- Trade name
- Model 1XL Black 39Model 1XL Black 38Model 1XL Black 36
- Device name
- Model 1 (Black, Blue, Grey, Light Grey, Lilac, White) - Model W (Anthracite, Sand) - Model H (Black, Open Grey, Sabot, Slipper)
- Model / reference
- MODEL 1 - MODEL W - MODEL H, FD0107
- Primary DI / UDI-DI
- 08057639746665, 08057639746603, 08057639746689
- Basic UDI-DI
- 805763974FD0NB
- EMDN code
- Y063303 Ready-made orthotic shoes
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000037941
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