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Norma Icon-3 automated 3-part differential hematology analyzer

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref NI30HModel Norma Icon-3

EMDN W0202010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062Icon3A2 Basic UDI-DIDate4 Feb 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

Model / Reference
Norma Icon-3, NI30H
Primary DI / UDI-DI
05999106200009
Basic UDI-DI
59991062Icon3A2
Direct Marketing DI
05999106200009
EMDN Code
W0202010201 Automated 3 part hematology analysers
Device Class
Class A
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000014244

Other devices from NORMA Instruments Zártkörűen Működő Részvénytársaság

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
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
  • New Device: No

Sources (1)

  • EUDAMED 264dfa1e-8e45-45a6-87e5-24286ce01733 61 fields · synced 22 Oct 2026