<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974671101622</udiDi>
    <basicUdiDi>B-06974671101622</basicUdiDi>
    <tradeName>06974671101622</tradeName>
    <deviceName>Free β human Chorionic Gonadotrophin Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CK-A014</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:09:20.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671101592</udiDi>
    <basicUdiDi>B-06974671101592</basicUdiDi>
    <tradeName>06974671101592</tradeName>
    <deviceName>Pregnancy Associated Plasma Protein A Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CK-A013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:09:16.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671101561</udiDi>
    <basicUdiDi>B-06974671101561</basicUdiDi>
    <tradeName>06974671101561</tradeName>
    <deviceName>Ferritin Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152206</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CK-A011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:09:14.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100779</udiDi>
    <basicUdiDi>B-06974671100779</basicUdiDi>
    <tradeName>06974671100779</tradeName>
    <deviceName>Carbohydrate Antigen 50 Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A008</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:08:02.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100762</udiDi>
    <basicUdiDi>B-06974671100762</basicUdiDi>
    <tradeName>06974671100762</tradeName>
    <deviceName>Neuron-specific Enolase Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A005</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:58.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100755</udiDi>
    <basicUdiDi>B-06974671100755</basicUdiDi>
    <tradeName>06974671100755</tradeName>
    <deviceName>Cytokeratin 19-Fragments Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A010</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:57.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100748</udiDi>
    <basicUdiDi>B-06974671100748</basicUdiDi>
    <tradeName>06974671100748</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A009</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:56.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100731</udiDi>
    <basicUdiDi>B-06974671100731</basicUdiDi>
    <tradeName>06974671100731</tradeName>
    <deviceName>Cancer Antigen 125 Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A007</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:55.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100724</udiDi>
    <basicUdiDi>B-06974671100724</basicUdiDi>
    <tradeName>06974671100724</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A006</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:51.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100717</udiDi>
    <basicUdiDi>B-06974671100717</basicUdiDi>
    <tradeName>06974671100717</tradeName>
    <deviceName>Carcinoembryonic Antigen Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:51.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100700</udiDi>
    <basicUdiDi>B-06974671100700</basicUdiDi>
    <tradeName>06974671100700</tradeName>
    <deviceName>Alpha-Fetoprotein Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CAL-CM-A001</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:50.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003700</udiDi>
    <basicUdiDi>B-06974521003700</basicUdiDi>
    <tradeName>CLIA hs-cTnT Calibrator</tradeName>
    <deviceName>CLIA hs-cTnT Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL007</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:19.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003663</udiDi>
    <basicUdiDi>B-06974521003663</basicUdiDi>
    <tradeName>CLIA FT4 Calibrator</tradeName>
    <deviceName>CLIA FT4 Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL016</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:19.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003649</udiDi>
    <basicUdiDi>B-06974521003649</basicUdiDi>
    <tradeName>CLIA FT3 Calibrator</tradeName>
    <deviceName>CLIA FT3 Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:14.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003625</udiDi>
    <basicUdiDi>B-06974521003625</basicUdiDi>
    <tradeName>CLIA FSH Calibrator</tradeName>
    <deviceName>CLIA FSH Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL023</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:12.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003595</udiDi>
    <basicUdiDi>B-06974521003595</basicUdiDi>
    <tradeName>CLIA FA Calibrator</tradeName>
    <deviceName>CLIA FA Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152206</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL029</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:07.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003571</udiDi>
    <basicUdiDi>B-06974521003571</basicUdiDi>
    <tradeName>CLIA E2 Calibrator</tradeName>
    <deviceName>CLIA E2 Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL021</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:05.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003557</udiDi>
    <basicUdiDi>B-06974521003557</basicUdiDi>
    <tradeName>CLIA CRP Calibrator</tradeName>
    <deviceName>CLIA CRP Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:00.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003533</udiDi>
    <basicUdiDi>B-06974521003533</basicUdiDi>
    <tradeName>CLIA Cortisol Calibrator</tradeName>
    <deviceName>CLIA Cortisol Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL024</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:36:59.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003519</udiDi>
    <basicUdiDi>B-06974521003519</basicUdiDi>
    <tradeName>CLIA BNP Calibrator</tradeName>
    <deviceName>CLIA BNP Calibrator</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:36:54.368Z</lastUpdated>
  </row>
</eudamedExport>