<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978139078174</udiDi>
    <basicUdiDi>B-06978139078174</basicUdiDi>
    <tradeName>Dengue IgG/IgM Antibody Test (GICA)</tradeName>
    <deviceName>Dengue IgG/IgM Antibody Test (GICA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320321002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:51.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139076095</udiDi>
    <basicUdiDi>B-06978139076095</basicUdiDi>
    <tradeName>Dengue NS1/IgG/IgM Test (GICA)</tradeName>
    <deviceName>Dengue NS1/IgG/IgM Test (GICA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Dengue NS1/IgG/IgM Test (GICA)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:33.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903340523</udiDi>
    <basicUdiDi>B-06977903340523</basicUdiDi>
    <tradeName>06977903340523</tradeName>
    <deviceName>Dengue NS1 Ag/Ab Combo Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</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>GS110409C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:08.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903340516</udiDi>
    <basicUdiDi>B-06977903340516</basicUdiDi>
    <tradeName>06977903340516</tradeName>
    <deviceName>Dengue NS1 Ag/Ab Combo Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</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>GS110409C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:07.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903340424</udiDi>
    <basicUdiDi>B-06977903340424</basicUdiDi>
    <tradeName>06977903340424</tradeName>
    <deviceName>Dengue IgM/IgG Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</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>GS110407C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:06.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903340417</udiDi>
    <basicUdiDi>B-06977903340417</basicUdiDi>
    <tradeName>06977903340417</tradeName>
    <deviceName>Dengue IgM/IgG Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</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>GS110407C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:03.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903340325</udiDi>
    <basicUdiDi>B-06977903340325</basicUdiDi>
    <tradeName>06977903340325</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</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>GS110405C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:02.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903340318</udiDi>
    <basicUdiDi>B-06977903340318</basicUdiDi>
    <tradeName>06977903340318</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</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>GS110405C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:01.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752385</udiDi>
    <basicUdiDi>B-06976374752385</basicUdiDi>
    <tradeName>Dengue Rapid Test Kit（Colloidal Gold）</tradeName>
    <deviceName>Dengue Rapid Test Kit（Colloidal Gold）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR043-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:09.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752378</udiDi>
    <basicUdiDi>B-06976374752378</basicUdiDi>
    <tradeName>Dengue Rapid Test Kit（Colloidal Gold）</tradeName>
    <deviceName>Dengue Rapid Test Kit（Colloidal Gold）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR043-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:07.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762562</udiDi>
    <basicUdiDi>B-06976202762562</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIDENg-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:27.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762555</udiDi>
    <basicUdiDi>B-06976202762555</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIDENb-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:26.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762548</udiDi>
    <basicUdiDi>B-06976202762548</basicUdiDi>
    <tradeName>Dengue IgG/IgM and NS1 Combo Test</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Combo Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIDEN-432</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:21.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762173</udiDi>
    <basicUdiDi>B-06976202762173</basicUdiDi>
    <tradeName>Dengue IgG/IgM and NS1 Combo Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIDEN-432</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:27.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975445472061</udiDi>
    <basicUdiDi>B-06975445472061</basicUdiDi>
    <tradeName>06975445472061</tradeName>
    <deviceName>Dengue Rapid Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>FARMASINO MEDICAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000026190</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Dengue Rapid Test Kit (Colloidal Gold Method)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:49:34.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201292</udiDi>
    <basicUdiDi>B-06975166201292</basicUdiDi>
    <tradeName>06975166201292</tradeName>
    <deviceName>Dengue IgG/IgM Antibody Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:30.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201285</udiDi>
    <basicUdiDi>B-06975166201285</basicUdiDi>
    <tradeName>06975166201285</tradeName>
    <deviceName>Dengue IgG/IgM Antibody Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:26.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201278</udiDi>
    <basicUdiDi>B-06975166201278</basicUdiDi>
    <tradeName>06975166201278</tradeName>
    <deviceName>Dengue IgG/IgM Antibody Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:25.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201261</udiDi>
    <basicUdiDi>B-06975166201261</basicUdiDi>
    <tradeName>06975166201261</tradeName>
    <deviceName>Dengue IgG/IgM Antibody Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 Test/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:24.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201216</udiDi>
    <basicUdiDi>B-06975166201216</basicUdiDi>
    <tradeName>06975166201216</tradeName>
    <deviceName>Dengue Antigen Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:02:17.212Z</lastUpdated>
  </row>
</eudamedExport>