Skip to content

Norma-iHClean

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref IC-81731Model Norma-iHClean

EMDN W0103010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062iHCleanV4 Basic UDI-DIDate2 Apr 2026RegisteredStatusActive

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-iHClean, IC-81731
Primary DI / UDI-DI
05999106200603, 05999106200214
Basic UDI-DI
59991062iHCleanV4
Direct Marketing DI
05999106200603
05999106200214
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
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
  • Reagent
  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 32ccdb62-5a98-4274-bc8e-7e6b72a8cddb 61 fields · synced 22 Oct 2026
  • EUDAMED 05999106200214|59991062IHCLEANV4 61 fields · synced 18 Jun 2026