Skip to content

Norma i3LAB demo automated 3-part differential hematology analyzer

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref NI31HDModel Norma i3LAB

EMDN W0202010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062i3LAB2K 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 i3LAB automated 3-part differential hematology analyzer
Model / Reference
Norma i3LAB, NI31HD
Primary DI / UDI-DI
05999106200405
Basic UDI-DI
59991062i3LAB2K
Direct Marketing DI
05999106200405
EMDN Code
W0202010201 Automated 3 part hematology analysers
Device Class
Class A

Manufacturer details

EUDAMED SRN
HU-MF-000014244

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 4232aca2-a11b-4ae1-808e-16d6ff8233d4 61 fields · synced 22 Oct 2026