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Hemo Control Hemoglobin Microcuvette

by EKF-diagnostic GmbH EUDAMED

Active European Union

Ref 3000-3112-0765

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  • Withdrawn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
Hemo Control Hemoglobin Microcuvettes
Model / Reference
3000-3112-0765
Primary DI / UDI-DI
24048534002459
Basic UDI-DI
4048534AFBBVE
Unit of Use DI
04048534002455
EMDN Code
W0103010601 Haemoglobin (hb)
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

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (8)

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