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<eudamedExport entity="devices">
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    <udiDi>06952804803179</udiDi>
    <basicUdiDi>B-06952804803179</basicUdiDi>
    <tradeName>Universal Transport Medium</tradeName>
    <deviceName>Universal Transport Medium</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010203</emdnCode>
    <emdnDescription>TRANSPORT MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F404D07</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:14.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803162</udiDi>
    <basicUdiDi>B-06952804803162</basicUdiDi>
    <tradeName>COVID-19 IgG Rapid Test</tradeName>
    <deviceName>COVID-19 IgG Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-W23002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:13.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803155</udiDi>
    <basicUdiDi>B-06952804803155</basicUdiDi>
    <tradeName>COVID-19 IgG Test Kit</tradeName>
    <deviceName>COVID-19 IgG Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-W35</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:11.817Z</lastUpdated>
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  <row>
    <udiDi>06952804803148</udiDi>
    <basicUdiDi>B-06952804803148</basicUdiDi>
    <tradeName>COVID-19 Neutralizing Antibody Rapid Test</tradeName>
    <deviceName>COVID-19 Neutralizing Antibody Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-W23001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:10.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803131</udiDi>
    <basicUdiDi>B-06952804803131</basicUdiDi>
    <tradeName>Multiple Drugs Saliva Test Kit</tradeName>
    <deviceName>Multiple Drugs Saliva Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-S322</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:04.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803124</udiDi>
    <basicUdiDi>B-06952804803124</basicUdiDi>
    <tradeName>Total T4 FIA</tradeName>
    <deviceName>Total T4 FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT4-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:03.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803117</udiDi>
    <basicUdiDi>B-06952804803117</basicUdiDi>
    <tradeName>Myoglobin FIA</tradeName>
    <deviceName>Myoglobin FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYO-W23G3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:02.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803094</udiDi>
    <basicUdiDi>B-06952804803094</basicUdiDi>
    <tradeName>CEA FIA</tradeName>
    <deviceName>CEA FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CEA-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:01.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803087</udiDi>
    <basicUdiDi>B-06952804803087</basicUdiDi>
    <tradeName>Total T3 FIA</tradeName>
    <deviceName>Total T3 FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT3-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:54.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803070</udiDi>
    <basicUdiDi>B-06952804803070</basicUdiDi>
    <tradeName>Anti-mullerian hormone FIA</tradeName>
    <deviceName>Anti-mullerian hormone FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMH-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:54.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803063</udiDi>
    <basicUdiDi>B-06952804803063</basicUdiDi>
    <tradeName>Ferritin FIA</tradeName>
    <deviceName>Ferritin FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRT-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:52.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803056</udiDi>
    <basicUdiDi>B-06952804803056</basicUdiDi>
    <tradeName>PropepsinⅡ FIA</tradeName>
    <deviceName>PropepsinⅡ FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG II-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:51.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803049</udiDi>
    <basicUdiDi>B-06952804803049</basicUdiDi>
    <tradeName>PropepsinⅠ FIA</tradeName>
    <deviceName>PropepsinⅠ FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG I-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:45.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802981</udiDi>
    <basicUdiDi>B-06952804802981</basicUdiDi>
    <tradeName>Testosterone FIA</tradeName>
    <deviceName>Testosterone FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TES-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:44.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802967</udiDi>
    <basicUdiDi>B-06952804802967</basicUdiDi>
    <tradeName>Cystatin C FIA</tradeName>
    <deviceName>Cystatin C FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYSC-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:42.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802950</udiDi>
    <basicUdiDi>B-06952804802950</basicUdiDi>
    <tradeName>Micro-Albumin FIA</tradeName>
    <deviceName>Micro-Albumin FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALB-U23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:42.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802943</udiDi>
    <basicUdiDi>B-06952804802943</basicUdiDi>
    <tradeName>Cathine Rapid Test</tradeName>
    <deviceName>Cathine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:35.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802936</udiDi>
    <basicUdiDi>B-06952804802936</basicUdiDi>
    <tradeName>Lactoferrin  Rapid Test</tradeName>
    <deviceName>Lactoferrin  Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010304</emdnCode>
    <emdnDescription>LACTOFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-F23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:34.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802929</udiDi>
    <basicUdiDi>B-06952804802929</basicUdiDi>
    <tradeName>Calprotectin  Rapid Test</tradeName>
    <deviceName>Calprotectin  Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPT-F23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:33.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802912</udiDi>
    <basicUdiDi>B-06952804802912</basicUdiDi>
    <tradeName>COVID-19&amp;FLU A/B FIA</tradeName>
    <deviceName>COVID-19&amp;FLU A/B FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-S22MF3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:32.269Z</lastUpdated>
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</eudamedExport>