<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974566303483</udiDi>
    <basicUdiDi>B-06974566303483</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM/NS1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-432</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:05.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566303476</udiDi>
    <basicUdiDi>B-06974566303476</basicUdiDi>
    <tradeName>Dengue NS1 Rapid Test</tradeName>
    <deviceName>Dengue NS1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-402</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:01.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001874</udiDi>
    <basicUdiDi>B-06974521001874</basicUdiDi>
    <tradeName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</tradeName>
    <deviceName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPG021025-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:31:56.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001867</udiDi>
    <basicUdiDi>B-06974521001867</basicUdiDi>
    <tradeName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</tradeName>
    <deviceName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPG021025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:31:55.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974473307161</udiDi>
    <basicUdiDi>B-06974473307161</basicUdiDi>
    <tradeName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:11:55.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018278</udiDi>
    <basicUdiDi>B-06974323018278</basicUdiDi>
    <tradeName>06974323018278</tradeName>
    <deviceName>Dengue Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:29.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018285</udiDi>
    <basicUdiDi>B-06974323018285</basicUdiDi>
    <tradeName>06974323018285</tradeName>
    <deviceName>Dengue Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:29.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018261</udiDi>
    <basicUdiDi>B-06974323018261</basicUdiDi>
    <tradeName>06974323018261</tradeName>
    <deviceName>Dengue Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:28.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238911107</udiDi>
    <basicUdiDi>B-06974238911107</basicUdiDi>
    <tradeName>Dengue IgG/IgM And NS1 Combo Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM And NS1 Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HDEN007GT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:51.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238911091</udiDi>
    <basicUdiDi>B-06974238911091</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Test</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HDEN006G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:51.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238911084</udiDi>
    <basicUdiDi>B-06974238911084</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HDEN005T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:50.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861682927</udiDi>
    <basicUdiDi>B-06973861682927</basicUdiDi>
    <tradeName>Anbio Dengue NS1 Ag&amp;IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Ag&amp;IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A10084001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:40:59.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861682910</udiDi>
    <basicUdiDi>B-06973861682910</basicUdiDi>
    <tradeName>06973861682910</tradeName>
    <deviceName>Dengue NS1 Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A10005001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:40:58.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861681661</udiDi>
    <basicUdiDi>B-06973861681661</basicUdiDi>
    <tradeName>06973861681661</tradeName>
    <deviceName>Dengue IgM/IgG Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A10004001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:40:53.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971792053410</udiDi>
    <basicUdiDi>B-06971792053410</basicUdiDi>
    <tradeName>Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KJ002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:37.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260163316035</udiDi>
    <basicUdiDi>B-04260163316035</basicUdiDi>
    <tradeName>Rapid Dengue NS1 Antigen Test Card</tradeName>
    <deviceName>Rapid Dengue NS1 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07DEN025AG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:25.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770011742660</udiDi>
    <basicUdiDi>B-03770011742660</basicUdiDi>
    <tradeName>TROD'DENGUE</tradeName>
    <deviceName>TROD'DENGUE</deviceName>
    <manufacturerName>AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000015889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-DEN-002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:22:13.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760309510675</udiDi>
    <basicUdiDi>B-03760309510675</basicUdiDi>
    <tradeName>Toda Dengdiag combo 1</tradeName>
    <deviceName>Toda Dengdiag combo 1</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22MT7-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:58:53.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760309510668</udiDi>
    <basicUdiDi>B-03760309510668</basicUdiDi>
    <tradeName>Toda Dengdiag combo 10</tradeName>
    <deviceName>Toda Dengdiag combo 10</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22MT7-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:58:52.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760309510651</udiDi>
    <basicUdiDi>B-03760309510651</basicUdiDi>
    <tradeName>Toda Dengdiag combo 20</tradeName>
    <deviceName>Toda Dengdiag combo 20</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22MT7-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:58:51.590Z</lastUpdated>
  </row>
</eudamedExport>