<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646DEN000EQRN</udiDi>
    <basicUdiDi>B-697424646DEN000EQRN</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>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:04:50.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CTNI000U8JT</udiDi>
    <basicUdiDi>B-697424646CTNI000U8JT</basicUdiDi>
    <tradeName>Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma)</tradeName>
    <deviceName>Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTNI-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:04:42.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712009349C</udiDi>
    <basicUdiDi>B-69717712009349C</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Dengue Rapid test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEG-W21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:14.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5N23C1ZC</udiDi>
    <basicUdiDi>B-5N23C1ZC</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Test (FIA)</tradeName>
    <deviceName>Dengue NS1 Antigen Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5N23C1-25-EU, 5N23C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:20.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5N04C1Z3</udiDi>
    <basicUdiDi>B-5N04C1Z3</basicUdiDi>
    <tradeName>Dengue IgG/IgM Combo Test (FIA)</tradeName>
    <deviceName>Dengue IgG/IgM Combo Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5N04C1-25-EU, 5N04C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:16.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-532919N-105A</udiDi>
    <basicUdiDi>B-nvm-532919N-105A</basicUdiDi>
    <tradeName>NADAL® Dengue NS1 Ag+IgG/IgM Test</tradeName>
    <deviceName>Dengue NS1 Ag+IgG/IgM Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>532919N-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:29.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C43A-25A3</udiDi>
    <basicUdiDi>B-WI-MICR-C43A-25A3</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C43A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:31:01.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C43A-109N</udiDi>
    <basicUdiDi>B-WI-MICR-C43A-109N</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C43A-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:31:01.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIDEg-402NX</udiDi>
    <basicUdiDi>B-VIDEg-402NX</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VIDEg-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:38.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIDEb-402M8</udiDi>
    <basicUdiDi>B-VIDEb-402M8</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VIDEb-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:37.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIDE-426KC</udiDi>
    <basicUdiDi>B-VIDE-426KC</basicUdiDi>
    <tradeName>Dengue IgG/IgM and NS1 Combo Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Combo Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VIDE-426</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:33.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20301W-25TWK</udiDi>
    <basicUdiDi>B-SC20301W-25TWK</basicUdiDi>
    <tradeName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</tradeName>
    <deviceName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20301W-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:24.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20301W-50TWK</udiDi>
    <basicUdiDi>B-SC20301W-50TWK</basicUdiDi>
    <tradeName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</tradeName>
    <deviceName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20301W-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:23.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20301W-20TW4</udiDi>
    <basicUdiDi>B-SC20301W-20TW4</basicUdiDi>
    <tradeName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</tradeName>
    <deviceName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20301W-20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:07.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20301W-1T26</udiDi>
    <basicUdiDi>B-SC20301W-1T26</basicUdiDi>
    <tradeName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</tradeName>
    <deviceName>Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20301W-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:07.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20201W-50TVY</udiDi>
    <basicUdiDi>B-SC20201W-50TVY</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20201W-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:46.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20201W-25TVY</udiDi>
    <basicUdiDi>B-SC20201W-25TVY</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20201W-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:44.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20201W-20TVH</udiDi>
    <basicUdiDi>B-SC20201W-20TVH</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20201W-20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:42.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20201W-1TZJ</udiDi>
    <basicUdiDi>B-SC20201W-1TZJ</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20201W-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:40.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20101W-50TVD</udiDi>
    <basicUdiDi>B-SC20101W-50TVD</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20101W-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:33.536Z</lastUpdated>
  </row>
</eudamedExport>