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H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials

by NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary EUDAMED

Ref HE5504Model NormaCont5+ control blood set for 5-part differential hematology analyzers

EMDN W0103010503

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062NormaCont56F Basic UDI-DIDate8 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
NormaCont5+ KIT K1 control blood set for 5-part differential Norma hematology analyzers
Model / Reference
NormaCont5+ control blood set for 5-part differential hematology analyzers, HE5504
Primary DI / UDI-DI
05999106200559
Basic UDI-DI
59991062NormaCont56F
Direct Marketing DI
05999106200559
EMDN Code
W0103010503 Multilevel blood controls
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
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 40278ea9-5a5a-428f-8526-e69ea4df2c55 61 fields · synced 22 Oct 2026