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Panbio™ Covid-19 Antigen Rapid Test Device Nasal

by Abbott Rapid Dx Galway EUDAMED

Withdrawn Not intended for the EU market

Ref 41FK21

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number539154303COV00118B Basic UDI-DIDate3 Jul 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 118152 0017 Amended

    Technical documentation EU IVDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    6 Jul 2026
    Expires
    3 May 2031
    Reason
    Other

Specification

EUDAMED

Device Name
The Panbio™ COVID-19 Ag Rapid Test Device Nasal
Model / Reference
41FK21
Primary DI / UDI-DI
05391543032487

Manufacturer details

EUDAMED SRN
IE-MF-000029637