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Hemolyzer® 3 NG automated 3-part differential hematology analyzer

by NORMA Instruments Zártkörűen Működő Részvénytársaság

Ref HE3100Model Norma Icon-3

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 Number59991062Icon3A2 Basic UDI-DI 05999106200412UDI-DIDate4 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  • Withdrawn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
Norma Icon-3 automated 3-part differential hematology analyzer
Model / Reference
Norma Icon-3, HE3100
Primary DI / UDI-DI
05999106200412
Basic UDI-DI
59991062Icon3A2
Direct Marketing DI
05999106200412
EMDN Code
W0202010201 Automated 3 part hematology analysers
Device Class
Class A
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000014244

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No