Skip to content

INNO-LiPA CFTR Italian Regional Strips <10T, CE>

by Fujirebio Europe N.V.

Ref 80579Model 80577

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54144700014U Basic UDI-DI 05414470805792UDI-DIDate16 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
INNO-LiPA CFTRiage Strips
Model / Reference
80577, 80579
Primary DI / UDI-DI
05414470805792
Basic UDI-DI
54144700014U
EMDN Code
W0106010101 Cystic fibrosis
Device Class
Class C
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001792

Other devices from Fujirebio Europe N.V.

See all devices from Fujirebio Europe N.V. →

Properties

  • 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