Skip to content

Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref HE5100Model Norma Icon-5

EMDN W0202010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062Icon5A6 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 automated 5-part differential hematology analyzer with closed sampling method
Model / Reference
Norma Icon-5, HE5100
Primary DI / UDI-DI
05999106200429
Basic UDI-DI
59991062Icon5A6
Direct Marketing DI
05999106200429
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class A
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000014244

Other devices from NORMA Instruments Zártkörűen Működő Részvénytársaság

See all devices from NORMA Instruments Zártkörűen Működő Részvénytársaság →

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 ab11a10e-d608-4ef9-95aa-d92e0e1ccf1c 61 fields · synced 22 Oct 2026