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    <tradeName>BioTracer™ Dengue NS1 Ag Rapid Card</tradeName>
    <deviceName>17212</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:35.468Z</lastUpdated>
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    <udiDi>08809317541167</udiDi>
    <basicUdiDi>B-08809317541167</basicUdiDi>
    <tradeName>BioTracer™ Dengue IgG/IgM Rapid Card</tradeName>
    <deviceName>17112</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
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    <udiDi>08683548257925</udiDi>
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    <tradeName>ChainFor Dengue Virus Detection qPCR Kit</tradeName>
    <deviceName>Dengue Virus Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <tradeName>OnSite® Dengue Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0063C-25T</reference>
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    <udiDi>00810114461112</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>OnSite® Dengue Ag Rapid Test</tradeName>
    <deviceName></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-20T</reference>
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    <lastUpdated>2026-07-08T06:51:30.638Z</lastUpdated>
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    <udiDi>00810114461129</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>OnSite® Dengue Ag Rapid Test</tradeName>
    <deviceName></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>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0063C-10T</reference>
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    <udiDi>00810114461136</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>Aria® Dengue Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0063C-30T-AR</reference>
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    <lastUpdated>2026-07-08T06:51:30.596Z</lastUpdated>
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    <udiDi>00810114461143</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>Aria® Dengue Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0063C-25T-AR</reference>
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    <lastUpdated>2026-07-08T06:51:30.569Z</lastUpdated>
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    <udiDi>00810114461150</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>Aria® Dengue Ag Rapid Test</tradeName>
    <deviceName></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-20T-AR</reference>
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    <lastUpdated>2026-07-08T06:51:30.546Z</lastUpdated>
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    <udiDi>00810114461167</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>Aria® Dengue Ag Rapid Test</tradeName>
    <deviceName></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-10T-AR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:51:30.524Z</lastUpdated>
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    <udiDi>00810114461600</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>OnSite® Dengue Ag Rapid Test</tradeName>
    <deviceName></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-50T</reference>
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    <lastUpdated>2026-07-08T06:51:30.449Z</lastUpdated>
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    <udiDi>00810114461617</udiDi>
    <basicUdiDi>081011446R0063CDU</basicUdiDi>
    <tradeName>Aria® Dengue Ag Rapid Test</tradeName>
    <deviceName></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-50T-AR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:51:30.428Z</lastUpdated>
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    <udiDi>08050616042262</udiDi>
    <basicUdiDi>B-08050616042262</basicUdiDi>
    <tradeName>Dengue virus NS1 Ag</tradeName>
    <deviceName>Dengue virus NS1 Ag</deviceName>
    <manufacturerName>DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000029123</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENS1AG.CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:32.173Z</lastUpdated>
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    <udiDi>06977698401966</udiDi>
    <basicUdiDi>B-06977698401966</basicUdiDi>
    <tradeName>Dengue IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold)</tradeName>
    <deviceName>Dengue IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</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>GKPD036</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:24.362Z</lastUpdated>
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    <basicUdiDi>B-06977698401911</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold)</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T22:28:22.757Z</lastUpdated>
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    <udiDi>06976753477861</udiDi>
    <basicUdiDi>B-06976753477861</basicUdiDi>
    <tradeName>Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KC010</reference>
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    <lastUpdated>2026-07-06T22:01:31.642Z</lastUpdated>
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    <tradeName>Dengue NS1 Rapid Test Device (whole blood/serum/plasma)</tradeName>
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    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A260501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:57.798Z</lastUpdated>
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    <basicUdiDi>B-06976753473405</basicUdiDi>
    <tradeName>Dengue IgGIgM Rapid Test Device (whole blood/serum/plasma)</tradeName>
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    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A250501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:56.994Z</lastUpdated>
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    <tradeName>Dengue Ag+IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue Ag+IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2201225</reference>
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    <lastUpdated>2026-07-06T17:53:00.247Z</lastUpdated>
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    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-422</reference>
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    <lastUpdated>2026-07-06T16:57:06.365Z</lastUpdated>
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