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INNO-LiPA CFTR19 Strips <20T, CE>

by Fujirebio Europe N.V. Belgium EUDAMED

Ref 80580Model 80577

EMDN W0106010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54144700014U Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
INNO-LiPA CFTRiage Strips
Model / Reference
80577, 80580
Primary DI / UDI-DI
05414470805808
Basic UDI-DI
54144700014U
EMDN Code
W0106010101 Cystic fibrosis
Device Class
Class C
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001792

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 05414470805808|54144700014U 61 fields · synced 23 Oct 2026