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HemoCue Plasma/Low Hb Photometer

by HemoCue AB United States EUDAMED

Ref 120307

EMDN W02020699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7311091203XXBE Basic UDI-DIDate12 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HemoCue Plasma/Low Hb Photometer
Model / Reference
120307
Primary DI / UDI-DI
07311091203076
Basic UDI-DI
7311091203XXBE
EMDN Code
W02020699 Rapid test hematology / histology / cytology instruments - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000000697

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 07311091203076|7311091203XXBE 61 fields · synced 24 Oct 2026