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Norma-iOptiClean

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref IC-81750Model Norma-iOptiClean

EMDN W0103010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062iOptiCleanC4 Basic UDI-DIDate29 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-iOptiClean, IC-81750
Primary DI / UDI-DI
05999106200610, 05999106200238
Basic UDI-DI
59991062iOptiCleanC4
Direct Marketing DI
05999106200610
05999106200238
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

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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 f18c52bd-860c-4eb8-9767-3637b53419c5 61 fields · synced 22 Oct 2026
  • EUDAMED 05999106200238|59991062IOPTICLEANC4 61 fields · synced 18 Jun 2026