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H3/5-CAL calibrator for Hemolyzer® hematology analyzers

by NORMA Instruments Zártkörűen Működő Részvénytársaság

Ref HE3611Model NormaCal3 calibrator

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 Number59991062NormaCalZ8 Basic UDI-DI 05999106200573UDI-DIDate6 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  • Withdrawn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
NormaCal3 calibrator for Norma hematology analyzers
Model / Reference
NormaCal3 calibrator, HE3611
Primary DI / UDI-DI
05999106200573
Basic UDI-DI
59991062NormaCalZ8
Direct Marketing DI
05999106200573
EMDN Code
W0103010507 Whole blood calibrators
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