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<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBL2281101A6</udiDi>
    <basicUdiDi>B-EBL2281101A6</basicUdiDi>
    <tradeName>D-EBL2281101A6</tradeName>
    <deviceName>Hematology Analyzer Fluorescent Platelets Calibrator</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2281101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:34.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2281100A4</udiDi>
    <basicUdiDi>B-EBL2281100A4</basicUdiDi>
    <tradeName>D-EBL2281100A4</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Calibrator</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2281100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:33.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22271009C</udiDi>
    <basicUdiDi>B-EBL22271009C</basicUdiDi>
    <tradeName>D-EBL22271009C</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2227100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:31.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL222610095</udiDi>
    <basicUdiDi>B-EBL222610095</basicUdiDi>
    <tradeName>D-EBL222610095</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2226100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:29.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22241008P</udiDi>
    <basicUdiDi>B-EBL22241008P</basicUdiDi>
    <tradeName>D-EBL22241008P</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2224100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:26.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22231008G</udiDi>
    <basicUdiDi>B-EBL22231008G</basicUdiDi>
    <tradeName>D-EBL22231008G</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2223100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:25.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL222210089</udiDi>
    <basicUdiDi>B-EBL222210089</basicUdiDi>
    <tradeName>D-EBL222210089</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2222100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:24.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL222110082</udiDi>
    <basicUdiDi>B-EBL222110082</basicUdiDi>
    <tradeName>D-EBL222110082</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2221100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:21.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22201007T</udiDi>
    <basicUdiDi>B-EBL22201007T</basicUdiDi>
    <tradeName>D-EBL22201007T</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2220100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:19.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22191009F</udiDi>
    <basicUdiDi>B-EBL22191009F</basicUdiDi>
    <tradeName>D-EBL22191009F</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2219100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:18.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL221810098</udiDi>
    <basicUdiDi>B-EBL221810098</basicUdiDi>
    <tradeName>D-EBL221810098</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2218100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:17.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22171008Z</udiDi>
    <basicUdiDi>B-EBL22171008Z</basicUdiDi>
    <tradeName>D-EBL22171008Z</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2217100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:14.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22161018U</udiDi>
    <basicUdiDi>B-EBL22161018U</basicUdiDi>
    <tradeName>D-EBL22161018U</tradeName>
    <deviceName>Hematology Analyzer Fluorescent Platelets Control</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>W0103010505</emdnCode>
    <emdnDescription>PLATELET CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2216101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:12.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22161008S</udiDi>
    <basicUdiDi>B-EBL22161008S</basicUdiDi>
    <tradeName>D-EBL22161008S</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2216100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:11.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22151008K</udiDi>
    <basicUdiDi>B-EBL22151008K</basicUdiDi>
    <tradeName>D-EBL22151008K</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2215100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:09.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL221310085</udiDi>
    <basicUdiDi>B-EBL221310085</basicUdiDi>
    <tradeName>D-EBL221310085</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2213100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:07.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22121017Y</udiDi>
    <basicUdiDi>B-EBL22121017Y</basicUdiDi>
    <tradeName>D-EBL22121017Y</tradeName>
    <deviceName>Hematology Analyzer Fluorescent Platelets Control</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>W0103010505</emdnCode>
    <emdnDescription>PLATELET CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2212101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:06.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22121007W</udiDi>
    <basicUdiDi>B-EBL22121007W</basicUdiDi>
    <tradeName>D-EBL22121007W</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2212100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:05.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22141008C</udiDi>
    <basicUdiDi>B-EBL22141008C</basicUdiDi>
    <tradeName>D-EBL22141008C</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2214100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:04.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22111017R</udiDi>
    <basicUdiDi>B-EBL22111017R</basicUdiDi>
    <tradeName>D-EBL22111017R</tradeName>
    <deviceName>Hematology Analyzer Fluorescent Platelets Control</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>W0103010505</emdnCode>
    <emdnDescription>PLATELET CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2211101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:46.682Z</lastUpdated>
  </row>
</eudamedExport>