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AURYX 90 H-FABP Reagent Kit

by PZ CORMAY Spółka Akcyjna EUDAMED

Active European Union

Ref I20-R0036Model AURYX 90 H-FABP Reagent Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514600885 Basic UDI-DIDate25 Jul 2025RegisteredStatusActive

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  • Withdrawn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
AURYX 90 H-FABP Reagent Kit, I20-R0036
Primary DI / UDI-DI
05907514600885
Basic UDI-DI
B-05907514600885
EMDN Code
W01021302 Heart-type fatty acid binding protein
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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