<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809328960872</udiDi>
    <basicUdiDi>880932896EMBCMT01BL</basicUdiDi>
    <tradeName>ASUREQUAN Analyzer</tradeName>
    <deviceName>ASUREQUAN Analyzer</deviceName>
    <manufacturerName>EMPECS Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000029619</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMBCMT01-EN01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:35.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809328960865</udiDi>
    <basicUdiDi>B-08809328960865</basicUdiDi>
    <tradeName>ASUREQUAN HbA1c</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EMPECS Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000029619</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP501001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:56:11.350Z</lastUpdated>
  </row>
</eudamedExport>