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EasyPGX ready MLH1

by Diatech Pharmacogenetics SRL EUDAMED

Active European Union

Ref RTX052

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8057289090301CRTX0523X Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
RTX052
Primary DI / UDI-DI
08057289091252
Basic UDI-DI
8057289090301CRTX0523X
Direct Marketing DI
08057289091252
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018670

Other devices from Diatech Pharmacogenetics SRL

See all devices from Diatech Pharmacogenetics SRL →

Properties

  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No