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ASUREQUAN Analyzer

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

Ref EMBCMT01-EN01Model EMBC-MT01

EMDN W0201060101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880932896EMBCMT01BL Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
EMBC-MT01, EMBCMT01-EN01
Primary DI / UDI-DI
08809328960872
Basic UDI-DI
880932896EMBCMT01BL
Direct Marketing DI
08809328960872
EMDN Code
W0201060101 Glycosilated hemoglobin devices
Device Class
Class A
Market of Registration
Italy

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
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED ff0423ff-56c9-4ea9-aae6-39c7393e5821 61 fields · synced 22 Oct 2026