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<eudamedExport entity="devices">
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    <udiDi>D-1877F</udiDi>
    <basicUdiDi>B-1877F</basicUdiDi>
    <tradeName>D-1877F</tradeName>
    <deviceName>Ischemia-Modified Albumin Assay Kit (Albumin-cobalt Binding Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:58:15.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129865</udiDi>
    <basicUdiDi>B-06974760129865</basicUdiDi>
    <tradeName>06974760129865</tradeName>
    <deviceName>Ischemia Modified Albumin （IMA）Assay Kit （Albumin Cobalt Binding Method）</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:05.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674869245</udiDi>
    <basicUdiDi>B-06971674869245</basicUdiDi>
    <tradeName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</tradeName>
    <deviceName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×1  R2:10mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:12.817Z</lastUpdated>
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  <row>
    <udiDi>06971674869238</udiDi>
    <basicUdiDi>B-06971674869238</basicUdiDi>
    <tradeName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</tradeName>
    <deviceName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:10mL×4（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:10.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674869221</udiDi>
    <basicUdiDi>B-06971674869221</basicUdiDi>
    <tradeName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</tradeName>
    <deviceName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40mL×2  R2:20mL×2（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:09.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674868408</udiDi>
    <basicUdiDi>B-06971674868408</basicUdiDi>
    <tradeName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</tradeName>
    <deviceName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality Control：1mL×1（92029）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:17.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674868057</udiDi>
    <basicUdiDi>B-06971674868057</basicUdiDi>
    <tradeName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</tradeName>
    <deviceName>Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator：1mL×2（91039）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:37:57.849Z</lastUpdated>
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