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Panbio™ Covid-19 Antigen Rapid Test Device Nasal

by Abbott Rapid Dx Galway 2 variants

Ref 41FK11

Active European Union

CE IVDR

Valid until

3 May 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 118152 0017 Date6 Jul 2026IssuedStatusActive EUDAMED: not on the EU market expires 3 May 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 118152 0017 Active Amended

    Technical documentation EU IVDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
The Panbio™ COVID-19 Ag Rapid Test Device Nasal
Model / Reference
41FK11
Primary DI / UDI-DI
05391543032470
Basic UDI-DI
539154303COV00118B
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class B

Manufacturer details

EUDAMED SRN
IE-MF-000029637

Properties

  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No