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AFIAS COVID-19/Flu A+B/RSV Ag Combo

by Boditech Med Inc. EUDAMED

Active European Union

Ref SMFP-113Model AFIAS COVID-19/Flu A+B/RSV Ag Combo

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08806133006726 Basic UDI-DIDate6 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
AFIAS COVID-19/Flu A+B/RSV Ag Combo, SMFP-113
Primary DI / UDI-DI
08806133006726
Basic UDI-DI
B-08806133006726
EMDN Code
W0105070599 Multiple infectious - multiplex assays - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000011028
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No