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Norma-iLyse5

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref IC-21751Model Norma-iLyse5

EMDN W0103010105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062iLyse5SK Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Norma-iLyse5, IC-21751
Primary DI / UDI-DI
05999106200641, 05999106200320
Basic UDI-DI
59991062iLyse5SK
Direct Marketing DI
05999106200641
05999106200320
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
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED c9fe5c41-7a88-4b48-b953-8896b446daa1 61 fields · synced 24 Oct 2026
  • EUDAMED 05999106200320|59991062ILYSE5SK 61 fields · synced 17 Jul 2026