Skip to content

EasyScreen™ Sample Processing Kit

by Genetic Signatures Ltd Australia EUDAMED

Ref SP012.1(CR)

EMDN W0105900103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number93511790SP012L7 Basic UDI-DIDate25 Mar 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

Model / Reference
SP012.1(CR)
Primary DI / UDI-DI
09351179000096
Basic UDI-DI
93511790SP012L7
EMDN Code
W0105900103 Supplemental na reagents
Device Class
Class A
Market of Registration
Ireland

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
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 69f5c430-6ea0-44d9-8db2-ea864117ce3a 61 fields · synced 22 Oct 2026