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EasyScreen

by Genetic Signatures Ltd Australia EUDAMED

Ref EV002-HT

EMDN W0105070504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09351179001086 Basic UDI-DIDate31 Oct 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
EasyScreen ® Enteric Virus Detection Kit
Model / Reference
EV002-HT
Primary DI / UDI-DI
09351179001086
Basic UDI-DI
B-09351179001086
EMDN Code
W0105070504 Gastrointestinal infections - multiplex na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000030901
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Genetic Signatures Limited

See all devices from Genetic Signatures Limited →

Properties & raw data

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

Sources (1)

  • EUDAMED 5cac05e9-8ae5-4ade-bb97-fbfde988b9b6 61 fields · synced 24 Oct 2026