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NormaCont5+ KIT KN control blood set for 5-part differential Norma hematology analyzers - 6 normal vials

by NORMA Instruments Zártkörűen Működő Részvénytársaság

Ref NIC-053KNModel NormaCont5+ control blood set for 5-part differential hematology analyzers

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59991062NormaCont56F Basic UDI-DI 05999106200184UDI-DIDate8 Feb 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

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, NIC-053KN
Primary DI / UDI-DI
05999106200184
Basic UDI-DI
59991062NormaCont56F
Direct Marketing DI
05999106200184
EMDN Code
W0103010501 Normal blood controls
Device Class
Class A
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000014244

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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