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H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials

by NORMA Instruments Zártkörűen Működő Részvénytársaság EUDAMED

Active European Union

Ref HE3505Model NormaCont3+ KIT K1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062NormaCont36B Basic UDI-DIDate5 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers
Model / Reference
NormaCont3+ KIT K1, HE3505
Primary DI / UDI-DI
05999106200542
Basic UDI-DI
59991062NormaCont36B
Direct Marketing DI
05999106200542
EMDN Code
W0103010501 Normal blood controls
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

  • 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