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EasyScreen™

by Genetic Signatures Ltd Australia EUDAMED

Ref PC-ENT-003

EMDN W0105080808

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-09351179004032 Basic UDI-DIDate23 Apr 2025RegisteredStatusActive

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™ Enteric PCR Positive Control
Model / Reference
PC-ENT-003
Primary DI / UDI-DI
09351179004032
Basic UDI-DI
B-09351179004032
EMDN Code
W0105080808 All infectious diseases controls - nat
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

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

Other devices from Genetic Signatures Ltd

See all devices from Genetic Signatures Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 6deaa8d1-8dcf-4e2e-9ef2-77d10a201466 61 fields · synced 22 Oct 2026