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Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref NO50HDModel Norma Icon-5 OP

EMDN W0202010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062Icon5OPU7 Basic UDI-DIDate6 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

Device Name
Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method
Model / Reference
Norma Icon-5 OP, NO50HD
Primary DI / UDI-DI
05999106200382
Basic UDI-DI
59991062Icon5OPU7
Direct Marketing DI
05999106200382
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class A

Manufacturer details

EUDAMED SRN
HU-MF-000014244

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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 dec938bb-47c4-44d2-9df4-978a7738bcbb 61 fields · synced 22 Oct 2026