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Extended IPU

by Sysmex Europe SE Germany EUDAMED

Ref ZE004218

EMDN W0202010192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426015434Extended-IPUE8 Basic UDI-DIDate6 Aug 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

Device Name
Extended IPU
Model / Reference
ZE004218
Primary DI / UDI-DI
04260154344009
Basic UDI-DI
426015434Extended-IPUE8
EMDN Code
W0202010192 Automated whole blood hematology analysers - IVD medical device software
Device Class
Class A
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000022332

Other devices from Sysmex Europe SE

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • 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
  • New Device: No

Sources (1)

  • EUDAMED 880b6bde-cc6b-499f-8cb7-38152ac734de 61 fields · synced 22 Oct 2026