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Hb-con low

by EKF-diagnostic GmbH EUDAMED

Active European Union

Ref 3000-6221

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 044132 0026 Date23 Jul 2026IssuedStatusActive expires 22 Oct 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 044132 0026 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    23 Jul 2026
    Expires
    22 Oct 2030
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Hb-con
Model / Reference
3000-6221
Primary DI / UDI-DI
04048534002479
Basic UDI-DI
4048534AFCBVH
EMDN Code
W0103010504 Haemoglobin controls
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006416

Other devices from Ekf Diagnostic GmbH

See all devices from Ekf Diagnostic GmbH →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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