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ASUREQUAN HbA1c

by EMPECS Medical Device Co., Ltd. South Korea EUDAMED

Ref CP501001Model ASUREQUAN HbA1c

EMDN W01010214

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809328960865 Basic UDI-DIDate6 May 2026RegisteredStatusActive

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
ASUREQUAN HbA1c, CP501001
Primary DI / UDI-DI
08809328960865
Basic UDI-DI
B-08809328960865
EMDN Code
W01010214 Glycosylated/glycated haemoglobin (cc)
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000029619
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from EMPECS Medical Device Co., Ltd.

Properties & raw data

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

Sources (1)

  • EUDAMED 4767c9d3-177f-4620-a0da-8ec8df1f20a7 61 fields · synced 22 Oct 2026