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Qlucore Diagnostics Platform

by Qlucore AB(publ) EUDAMED

Active European Union

Ref QD Platform,

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number07350148191KA Basic UDI-DIDate3 Feb 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  • Withdrawn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

Device Name
Qlucore Diagnostics Platform
Model / Reference
QD Platform
Primary DI / UDI-DI
07350148190006
Basic UDI-DI
07350148191KA
Direct Marketing DI
07350148190006
EMDN Code
W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
Device Class
Class A
Special Device Type
Software
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
SE-MF-000030781

Properties

  • Human Tissues
  • New Device

Other properties (9)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No