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Model 1XL Black 39

by Well Walking S.r.l.

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 European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805763974FD0NB Basic UDI-DI Date12 Jun 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade name
Model 1XL Black 39
Model 1XL Black 38
Model 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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Properties

Other properties (14, all answered No)