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Mindpeak Breast Ki-67 4R

by Mindpeak GmbH Germany EUDAMED

Ref Ki-67-4R EMDN W02069092

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04262392420057 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Mindpeak Breast Ki-67 4R
Model / Reference
Ki-67-4R
Primary DI / UDI-DI
04262392420057
Basic UDI-DI
B-04262392420057
EMDN Code
W02069092 Various sample processing instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031982

Other devices from Mindpeak GmbH

See all devices from Mindpeak GmbH →

Properties & raw data

Show properties, registry sources and raw records
Other properties (10)
  • Sterile: No
  • Human Tissues: 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

Sources (1)

  • EUDAMED 27f134c8-0f77-4d66-8df2-dba266f80e9c 61 fields · synced 23 Oct 2026