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<eudamedExport entity="devices">
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    <udiDi>06942253004470</udiDi>
    <basicUdiDi>B-06942253004470</basicUdiDi>
    <tradeName>AutoChem Lp(a)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038143</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>360103LPA000S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:10:35.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050416379</udiDi>
    <basicUdiDi>B-ECH050416379</basicUdiDi>
    <tradeName>D-ECH050416379</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0504163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:45:13.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050316372</udiDi>
    <basicUdiDi>B-ECH050316372</basicUdiDi>
    <tradeName>D-ECH050316372</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0503163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:34.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05021636T</udiDi>
    <basicUdiDi>B-ECH05021636T</basicUdiDi>
    <tradeName>D-ECH05021636T</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:48.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05011636L</udiDi>
    <basicUdiDi>B-ECH05011636L</basicUdiDi>
    <tradeName>D-ECH05011636L</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:15.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01091636Q</udiDi>
    <basicUdiDi>B-ECH01091636Q</basicUdiDi>
    <tradeName>D-ECH01091636Q</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0109163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:23.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01051635U</udiDi>
    <basicUdiDi>B-ECH01051635U</basicUdiDi>
    <tradeName>D-ECH01051635U</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:34.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01011634Y</udiDi>
    <basicUdiDi>B-ECH01011634Y</basicUdiDi>
    <tradeName>D-ECH01011634Y</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:08.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975838802154</udiDi>
    <basicUdiDi>B-06975838802154</basicUdiDi>
    <tradeName>06975838802154</tradeName>
    <deviceName>Lipoprotein (a) Assay Kit</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:14:04.809Z</lastUpdated>
  </row>
</eudamedExport>