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GenomEra® GBS Assay Kit

by Abacus Diagnostica Oy Finland EUDAMED

Ref CDX-60-01-40Model CDX-60 EMDN W0105011102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CDX-60-01-40VB 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  • Withdrawn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European Union — CE/IVDD Withdrawn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 25 Oct 2026

Model / Reference
CDX-60, CDX-60-01-40
Primary DI / UDI-DI
D-CDX-60-01-40VB
Basic UDI-DI
B-CDX-60-01-40VB
EMDN Code
W0105011102 Streptococcal detection by 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 0c547fe0-8448-4907-a4c6-4710f810f721 61 fields · synced 25 Oct 2026