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EasyScreen

by Genetic Signatures Ltd Australia EUDAMED

Ref PE001-MT Panel D

EMDN W0105070504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-09351179001345 Basic UDI-DIDate1 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
EasyScreen™ Pan-Enteric Pathogen Detection Kit
Model / Reference
PE001-MT Panel D
Primary DI / UDI-DI
09351179001345
Basic UDI-DI
B-09351179001345
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

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 b293c02d-59cb-4b5f-92bf-0e06f4d51ff6 61 fields · synced 22 Oct 2026