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HemoCue Hb 301 Microcuvettes

by HemoCue AB United States EUDAMED

Ref 111804 EMDN W0501010199,W0501010299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7311091118XXC3 Basic UDI-DIDate8 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
HemoCue Hb 301 Microcuvettes
Model / Reference
111804
Primary DI / UDI-DI
17311091118049
Basic UDI-DI
7311091118XXC3
Unit of Use DI
07311091118004
EMDN Code
W0501010199,W0501010299
Device Class
Class A
Market of Registration
Portugal

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
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 17311091118049|7311091118XXC3 61 fields · synced 25 Oct 2026