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HbA1c test kit (24 tests)

by EUROLyser Diagnostica GmbH Austria EUDAMED

Ref ST0110

EMDN W0102160102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ST0110CV Basic UDI-DIDate21 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
ST0110
Primary DI / UDI-DI
D-ST0110CV
Basic UDI-DI
B-ST0110CV
EMDN Code
W0102160102 Glycosylated/glycated haemoglobin (ic) rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000013746

Other devices from EUROLyser Diagnostica GmbH

See all devices from EUROLyser Diagnostica GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e2879118-67d7-4032-b177-b4e0c6003621 61 fields · synced 22 Oct 2026