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<eudamedExport entity="devices">
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    <udiDi>06903053022736</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028631-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053022743</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028632-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053022750</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028633-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.052Z</lastUpdated>
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  <row>
    <udiDi>06903053022767</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028634-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053022774</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028635-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053022828</udiDi>
    <basicUdiDi>69449040XQSJ-003J******A4</basicUdiDi>
    <tradeName>BC-BF Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028640-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:56.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590704827</udiDi>
    <basicUdiDi>150995901HEMCONTROL9R</basicUdiDi>
    <tradeName>COULTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07297</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:49:41.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026603</udiDi>
    <basicUdiDi>B-06945429026603</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:58.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026597</udiDi>
    <basicUdiDi>B-06945429026597</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:57.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026580</udiDi>
    <basicUdiDi>B-06945429026580</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026573</udiDi>
    <basicUdiDi>B-06945429026573</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:50.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026566</udiDi>
    <basicUdiDi>B-06945429026566</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:49.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026559</udiDi>
    <basicUdiDi>B-06945429026559</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:48.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026542</udiDi>
    <basicUdiDi>B-06945429026542</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:47.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026535</udiDi>
    <basicUdiDi>B-06945429026535</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:39.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026528</udiDi>
    <basicUdiDi>B-06945429026528</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:38.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026511</udiDi>
    <basicUdiDi>B-06945429026511</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:37.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026504</udiDi>
    <basicUdiDi>B-06945429026504</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Low value:6560-ER00001 Normal value:6560-ER00002 High value:6560-ER00003</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:36.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026498</udiDi>
    <basicUdiDi>B-06945429026498</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Low value:6560-ER00001 Normal value:6560-ER00002 High value:6560-ER00003</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:30.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413840355</udiDi>
    <basicUdiDi>69444138HematoryCon90DAZ</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-90D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:41:11.577Z</lastUpdated>
  </row>
</eudamedExport>