Skip to content

HemoCue Hb 201 DM Analyzer

by HemoCue AB United States EUDAMED

Ref 121131

EMDN W02020699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7311091211XXBB 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 Hb 201 DM Analyzer
Model / Reference
121131
Primary DI / UDI-DI
07311091211316
Basic UDI-DI
7311091211XXBB
EMDN Code
W02020699 Rapid test hematology / histology / cytology instruments - other
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
SE-MF-000000697

Other devices from Hemocue Ab

See all devices from Hemocue Ab →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 07311091211316|7311091211XXBB 61 fields · synced 24 Oct 2026