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HemoCue Glucose 201 DM Analyzer

by HemoCue AB EUDAMED

Active European Union EUDAMED: not on the EU market

Ref 121478

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7311091214XXBS Basic UDI-DIDate12 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
HemoCue Glucose 201 DM Analyzer
Model / Reference
121478
Primary DI / UDI-DI
07311091214782
Basic UDI-DI
7311091214XXBS
EMDN Code
W0201060102, W0201069099
Device Class
Class A

Manufacturer details

EUDAMED SRN
SE-MF-000000697

Other devices from Hemocue Ab

See all devices from Hemocue Ab →

Properties

  • 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