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HemoCue Plasma/Low Hb Microcuvettes

by HemoCue AB FDA registration: Sweden EUDAMED

Ref 110310 EMDN W0103010601

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-17311091103106 Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HemoCue Plasma/Low Hb Microcuvettes
Model / Reference
110310
Primary DI / UDI-DI
17311091103106
Basic UDI-DI
B-17311091103106
EMDN Code
W0103010601 Haemoglobin (hb)
Device Class
Class IVD General
Market of Registration
Croatia

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
  • 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

Sources (1)

  • EUDAMED 17311091103106|B-17311091103106 61 fields · synced 24 Oct 2026