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<eudamedExport entity="devices">
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    <udiDi>D-000041242SI003-254C</udiDi>
    <basicUdiDi>B-000041242SI003-254C</basicUdiDi>
    <tradeName>D-000041242SI003-254C</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI003-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:50.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000041242SI003-0546</udiDi>
    <basicUdiDi>B-000041242SI003-0546</basicUdiDi>
    <tradeName>D-000041242SI003-0546</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI003-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:49.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000041242SI003-013W</udiDi>
    <basicUdiDi>B-000041242SI003-013W</basicUdiDi>
    <tradeName>D-000041242SI003-013W</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI003-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:47.753Z</lastUpdated>
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  <row>
    <udiDi>D-000041242IAB001-25YW</udiDi>
    <basicUdiDi>B-000041242IAB001-25YW</basicUdiDi>
    <tradeName>D-000041242IAB001-25YW</tradeName>
    <deviceName>Influenza A+B Antigen Rapid Test Kit (Nasal Swab Test)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAB001-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:45.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000041242IAB001-05YQ</udiDi>
    <basicUdiDi>B-000041242IAB001-05YQ</basicUdiDi>
    <tradeName>D-000041242IAB001-05YQ</tradeName>
    <deviceName>Influenza A+B Antigen Rapid Test Kit (Nasal Swab Test)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAB001-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:43.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000041242IAB001-01YG</udiDi>
    <basicUdiDi>B-000041242IAB001-01YG</basicUdiDi>
    <tradeName>D-000041242IAB001-01YG</tradeName>
    <deviceName>Influenza A+B Antigen Rapid Test Kit (Nasal Swab Test)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAB001-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:42.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000041242DEN003-256L</udiDi>
    <basicUdiDi>B-000041242DEN003-256L</basicUdiDi>
    <tradeName>D-000041242DEN003-256L</tradeName>
    <deviceName>Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN003-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:41.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000041242DEN003-056E</udiDi>
    <basicUdiDi>B-000041242DEN003-056E</basicUdiDi>
    <tradeName>D-000041242DEN003-056E</tradeName>
    <deviceName>Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN003-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:38.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000041242DEN003-0166</udiDi>
    <basicUdiDi>B-000041242DEN003-0166</basicUdiDi>
    <tradeName>D-000041242DEN003-0166</tradeName>
    <deviceName>Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN003-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:37.350Z</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>
</eudamedExport>