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Premium Elasticated Wrist Support Small

by Fima Global Brands Ltd

Ref INT-021(1)Model FORTUNA -PREMIUM ELASTICATED WRIST SUPPORT

Premium Elasticated Wrist Support Small (INT-021(1)) is a Class I device made by Fima Global Brands Ltd, registered in EUDAMED on 29 Nov 2025 (Basic UDI-DI 506098242INT-021-023BU), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506098242INT-021-023BU Basic UDI-DI 05060982422073UDI-DIDate29 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Device name
Fortuna -Premium Elasticated Wrist Support
Model / reference
FORTUNA -PREMIUM ELASTICATED WRIST SUPPORT, INT-021(1)
Primary DI / UDI-DI
05060982422073
Basic UDI-DI
506098242INT-021-023BU
EMDN code
Y060612 Wrist-hand orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
UK-MF-000036604
Authorised representative
GLORY-Cosmetic Hungary Kft. HU-AR-000035374

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Properties

Other properties (14, all answered No)