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Ki-67 Quantifier clinical

by VMscope GmbH Germany EUDAMED

Ref Ki-67 Quantifier clinical

EMDN W02029092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04262370480011 Basic UDI-DIDate13 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Ki-67 Quantifier clinical
Primary DI / UDI-DI
04262370480011
Basic UDI-DI
B-04262370480011
EMDN Code
W02029092 Various hematology / histology / cytology instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000023540

Other devices from VMscope GmbH

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 0629322e-5d51-4201-b9a7-a71fa577d3eb 61 fields · synced 22 Oct 2026