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<eudamedExport entity="devices">
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    <udiDi>03610230008898</udiDi>
    <basicUdiDi>361023minotrol_reticB2</basicUdiDi>
    <tradeName>ABX Minotrol Retic</tradeName>
    <deviceName>ABX Minotrol Retic</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2072201, 2072202, 1300136023, 1300136026, 1300136029</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:12:48.705Z</lastUpdated>
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  <row>
    <udiDi>D-628028Q9</udiDi>
    <basicUdiDi>B-628028Q9</basicUdiDi>
    <tradeName>COULTER Retic-X Cell Control</tradeName>
    <deviceName>COULTER Retic-X Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628028</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:39:07.551Z</lastUpdated>
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  <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>
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    <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>
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  <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>
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    <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>
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  <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-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>
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    <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>
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    <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>
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    <udiDi>D-EBL22111007P</udiDi>
    <basicUdiDi>B-EBL22111007P</basicUdiDi>
    <tradeName>D-EBL22111007P</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>EBL2211100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:45.883Z</lastUpdated>
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    <udiDi>D-EBL22101007G</udiDi>
    <basicUdiDi>B-EBL22101007G</basicUdiDi>
    <tradeName>D-EBL22101007G</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>EBL2210100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:44.279Z</lastUpdated>
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    <udiDi>D-EBL220910094</udiDi>
    <basicUdiDi>B-EBL220910094</basicUdiDi>
    <tradeName>D-EBL220910094</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>EBL2209100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:39.780Z</lastUpdated>
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