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Elastic Elbow Support (M) – Beige

by Fima Global Brands Ltd

Ref PE030Model PREMIA – ELASTICATED - ELBOW SUPPORT

Elastic Elbow Support (M) – Beige (PE030) is a Class I device made by Fima Global Brands Ltd, registered in EUDAMED on 28 Jan 2026 (Basic UDI-DI 506098242PEO029-032YA), 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 Number506098242PEO029-032YA Basic UDI-DI 05060982421588UDI-DIDate28 Jan 2026RegisteredStatusActive

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  • Withdrawn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
Premia – Elasticated - Elbow Support
Model / reference
PREMIA – ELASTICATED - ELBOW SUPPORT, PE030
Primary DI / UDI-DI
05060982421588
Basic UDI-DI
506098242PEO029-032YA
EMDN code
Y060615 Elbow 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)