Skip to content

GenomEra Norovirus Assay kit

by Abacus Diagnostica Oy Finland EUDAMED

Ref CDX-100-01-20Model CDX-100 EMDN W0105040516

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CDX-100-01-20JQ Basic UDI-DIDate25 Aug 2022RegisteredStatusWithdrawn

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CDX-100, CDX-100-01-20
Primary DI / UDI-DI
D-CDX-100-01-20JQ
Basic UDI-DI
B-CDX-100-01-20JQ
EMDN Code
W0105040516 Norovirus - na reagents
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000024114

Properties & raw data

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

Sources (1)

  • EUDAMED e6417be5-cfd9-4fdf-8dd3-e04d76170e8c 61 fields · synced 24 Oct 2026