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Norma-iRP51

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref IC-91751, IC-91771Model Norma-iRP51 , Norma-iRP51 OP

EMDN W0103010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062iRP56T Basic UDI-DIDate19 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

Trade Name
Norma-iRP51
Norma-iRP51 OP
Model / Reference
Norma-iRP51, IC-91751, Norma-iRP51 OP, IC-91771
Primary DI / UDI-DI
05999106200078, 05999106200092
Basic UDI-DI
59991062iRP56T, 59991062iRP5OPC2
Direct Marketing DI
05999106200078
05999106200092
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

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing NoEUDAMEDYesEUDAMED
  • 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 12aa77fe-be45-47b1-bd6a-0a17298b13f2 61 fields · synced 24 Oct 2026
  • EUDAMED 05999106200092|59991062IRP5OPC2 61 fields · synced 18 May 2026