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<eudamedExport entity="devices">
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    <udiDi>+ENTIRE585810L</udiDi>
    <basicUdiDi>B-+ENTIRE585810L</basicUdiDi>
    <tradeName>+ENTIRE585810L</tradeName>
    <deviceName>Dengue Virus IgM µ-capture</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58581</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:02.128Z</lastUpdated>
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  <row>
    <udiDi>+ENTINS1D40200O</udiDi>
    <basicUdiDi>B-+ENTINS1D40200O</basicUdiDi>
    <tradeName>+ENTINS1D40200O</tradeName>
    <deviceName>NovaLisa® Dengue Virus NS1 Antigen</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NS1D4020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:03.955Z</lastUpdated>
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  <row>
    <udiDi>+ENTIDVM0640DS0R</udiDi>
    <basicUdiDi>B-+ENTIDVM0640DS0R</basicUdiDi>
    <tradeName>+ENTIDVM0640DS0R</tradeName>
    <deviceName>NovaLisa® Dengue Virus IgM µ-capture</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVM0640DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:13.102Z</lastUpdated>
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    <udiDi>+ENTIDVM06400T</udiDi>
    <basicUdiDi>B-+ENTIDVM06400T</basicUdiDi>
    <tradeName>+ENTIDVM06400T</tradeName>
    <deviceName>NovaLisa® Dengue Virus IgM µ-capture</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVM0640</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:12.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDENG0120DS0K</udiDi>
    <basicUdiDi>B-+ENTIDENG0120DS0K</basicUdiDi>
    <tradeName>+ENTIDENG0120DS0K</tradeName>
    <deviceName>NovaLisa® Dengue Virus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENG0120DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:28.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDENG01200M</udiDi>
    <basicUdiDi>B-+ENTIDENG01200M</basicUdiDi>
    <tradeName>+ENTIDENG01200M</tradeName>
    <deviceName>NovaLisa® Dengue Virus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENG0120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:27.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDENM0120DS0Q</udiDi>
    <basicUdiDi>B-+ENTIDENM0120DS0Q</basicUdiDi>
    <tradeName>+ENTIDENM0120DS0Q</tradeName>
    <deviceName>NovaLisa® Dengue Virus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENM0120DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:26.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDENM01200S</udiDi>
    <basicUdiDi>B-+ENTIDENM01200S</basicUdiDi>
    <tradeName>+ENTIDENM01200S</tradeName>
    <deviceName>NovaLisa® Dengue Virus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENM0120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:25.979Z</lastUpdated>
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  <row>
    <udiDi>00810114460023</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>OnSite® Dengue Ag Rapid Test</tradeName>
    <deviceName>Dengue Ag Rapid Test</deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0063C</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:43.801Z</lastUpdated>
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  <row>
    <udiDi>D-TD-HNKX-CED-554E</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-554E</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-554E</tradeName>
    <deviceName>Dengue IgG &amp; IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:21.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-5044</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-5044</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-5044</tradeName>
    <deviceName>Dengue Virus Antigen Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:02.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD156XR</udiDi>
    <basicUdiDi>B-GKPD156XR</basicUdiDi>
    <tradeName>Dengue IgG/IgM Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Dengue IgG/IgM Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD156</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:43.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCDEN-425aUL</udiDi>
    <basicUdiDi>B-GCDEN-425aUL</basicUdiDi>
    <tradeName>Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>GCDEN-425a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:50.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCDEN(ab)-402eQG</udiDi>
    <basicUdiDi>B-GCDEN(ab)-402eQG</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>GCDEN(ab)-402e</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:46.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCDEN(ab)-402cQC</udiDi>
    <basicUdiDi>B-GCDEN(ab)-402cQC</basicUdiDi>
    <tradeName>Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>GCDEN(ab)-402c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:43.143Z</lastUpdated>
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  <row>
    <udiDi>D-GCDEN(NS)-402dAS</udiDi>
    <basicUdiDi>B-GCDEN(NS)-402dAS</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>GCDEN(NS)-402d</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:37.517Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000054349CR022GD</udiDi>
    <basicUdiDi>B-CNMF000054349CR022GD</basicUdiDi>
    <tradeName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:45.134Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000054349CR011G8</udiDi>
    <basicUdiDi>B-CNMF000054349CR011G8</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:36.329Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000054349CR010G6</udiDi>
    <basicUdiDi>B-CNMF000054349CR010G6</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:34.714Z</lastUpdated>
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  <row>
    <udiDi>08809317541181</udiDi>
    <basicUdiDi>B-08809317541181</basicUdiDi>
    <tradeName>BioTracer™ Dengue Combo Rapid Card</tradeName>
    <deviceName>17311</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:36.275Z</lastUpdated>
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</eudamedExport>