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H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials

by NORMA Instruments Zártkörűen Működő Részvénytársaság EUDAMED

Active European Union

Ref HE3504Model 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  • Withdrawn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, HE3504
Primary DI / UDI-DI
05999106200535
Basic UDI-DI
59991062NormaCont36B
Direct Marketing DI
05999106200535
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

Show 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