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AURYX 90 CA19-9 Reagent Kit

by PZ CORMAY Spółka Akcyjna Poland EUDAMED

Ref I20-R0108Model AURYX 90 CA19-9 Reagent Kit EMDN W0102030103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514600472 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
AURYX 90 CA19-9 Reagent Kit, I20-R0108
Primary DI / UDI-DI
05907514600472
Basic UDI-DI
B-05907514600472
EMDN Code
W0102030103 Cancer antigen 19-9
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

Other devices from PZ CORMAY Spółka Akcyjna

See all devices from PZ CORMAY Spółka Akcyjna →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED b9892746-02e4-4ab9-b87a-623caa9b25bc 61 fields · synced 22 Oct 2026