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Hellabio HSC02

by Δημητριαδης Ιωαννης & Υιος Ικε Hellabio EUDAMED

Active European Union

Ref HSC02Model Quality Controls

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number521301229CONTROLSMX Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Quality Controls
Model / Reference
Quality Controls, HSC02
Primary DI / UDI-DI
05213012290238
Basic UDI-DI
521301229CONTROLSMX
EMDN Code
W0103010599 Haematology controls - other
Device Class
Class B
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
EL-MF-000055001

Other devices from Δημητριαδης Ιωαννης & Υιος Ικε Hellabio

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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