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Surgical Gown Impervious X-Large

by Arabian Medical Products Manufacturing Company (Enayah) EUDAMED

Active European Union

Ref EN63845-02

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6281141EN04UU Basic UDI-DIDate28 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sterile Surgical Gowns
Model / Reference
EN63845-02
Primary DI / UDI-DI
62811410560172
Direct Marketing DI
62811410560172

Manufacturer details

EUDAMED SRN
SA-MF-000012228
Authorised representative
MDSS GmbH DE-AR-000005430

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