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<eudamedExport entity="devices">
  <row>
    <udiDi>D-000012807086165QZ</udiDi>
    <basicUdiDi>B-000012807086165QZ</basicUdiDi>
    <tradeName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-FE031A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:09.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000012807086266R8</udiDi>
    <basicUdiDi>B-000012807086266R8</basicUdiDi>
    <tradeName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-FE031B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:07.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975496250083</udiDi>
    <basicUdiDi>697549625BTT012SH</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTT012-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:12:46.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975496250052</udiDi>
    <basicUdiDi>697549625BTT011SF</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Test Kit(Colloidal Gold)</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test Kit(Colloidal Gold)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTT011-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:15:03.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804832728</udiDi>
    <basicUdiDi>69528048A4287002H</basicUdiDi>
    <tradeName>Dengue Rapid Test</tradeName>
    <deviceName>Dengue Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A42870</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:33:52.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581269</udiDi>
    <basicUdiDi>697518250G1181132</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11811</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:25:12.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581252</udiDi>
    <basicUdiDi>697518250G118102Y</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11810</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:25:06.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293580798</udiDi>
    <basicUdiDi>697518250G1181336</basicUdiDi>
    <tradeName>Dengue NS1 Antigen &amp; IgG/IgM Combo Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Antigen &amp; IgG/IgM Combo Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11813</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:05.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206308</udiDi>
    <basicUdiDi>B-06933260206308</basicUdiDi>
    <tradeName>Dengue Ag &amp;Ab Combo Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0101801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:26.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206292</udiDi>
    <basicUdiDi>B-06933260206292</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0101701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:25.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260204083</udiDi>
    <basicUdiDi>B-06933260204083</basicUdiDi>
    <tradeName>BIOTIME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0101601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:50:43.983Z</lastUpdated>
  </row>
</eudamedExport>