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    <tradeName>++B379DNS1RDSXB</tradeName>
    <deviceName>Dengue NS1 Detect™ Rapid Test</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNS1-RD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <udiDi>++B379DNS11ZK</udiDi>
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    <deviceName>DENV Detect™ NS1 ELISA</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNS1-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:12.665Z</lastUpdated>
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    <udiDi>++B379DDMS1ZJ</udiDi>
    <basicUdiDi>B-++B379DDMS1ZJ</basicUdiDi>
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    <deviceName>DENV Detect™ IgM Capture ELISA</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
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    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDMS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:11.188Z</lastUpdated>
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    <udiDi>++B379DDGS1YL</udiDi>
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    <tradeName>++B379DDGS1YL</tradeName>
    <deviceName>DENV Detect™ IgG ELISA</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDGS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:08.658Z</lastUpdated>
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    <udiDi>08806133042212</udiDi>
    <basicUdiDi>880613300028BR</basicUdiDi>
    <tradeName>ichroma™ Dengue NS1 Ag</tradeName>
    <deviceName>ichroma™ Dengue NS1 Ag</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-62</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:49.345Z</lastUpdated>
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    <udiDi>08806133042137</udiDi>
    <basicUdiDi>880613300027BP</basicUdiDi>
    <tradeName>ichroma™ Dengue IgG/IgM</tradeName>
    <deviceName>ichroma™ Dengue IgG/IgM</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-60</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:49.153Z</lastUpdated>
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    <udiDi>08806133042090</udiDi>
    <basicUdiDi>880613300548CQ</basicUdiDi>
    <tradeName>AFIAS Dengue IgG/IgM</tradeName>
    <deviceName>AFIAS Dengue IgG/IgM</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-41</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:42.565Z</lastUpdated>
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    <udiDi>03573026608217</udiDi>
    <basicUdiDi>357302BUDI000852U5</basicUdiDi>
    <tradeName>VIDAS® DENGUE NS1 Ag</tradeName>
    <deviceName>VIDAS® DENGUE NS1 Ag</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423077</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:56.122Z</lastUpdated>
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    <udiDi>D-FI-DEC-435J7</udiDi>
    <basicUdiDi>B-FI-DEC-435J7</basicUdiDi>
    <tradeName>Dengue IgG, IgM and NS1 Combo Test Cassette</tradeName>
    <deviceName>Dengue IgG, IgM and NS1 Combo Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-DEC-435</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:38.702Z</lastUpdated>
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    <udiDi>D-FI-DES-402P8</udiDi>
    <basicUdiDi>B-FI-DES-402P8</basicUdiDi>
    <tradeName>Dengue NS1 Test Cassette</tradeName>
    <deviceName>Dengue NS1 Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-DES-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:55.993Z</lastUpdated>
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    <udiDi>D-FI-DEN-402MH</udiDi>
    <basicUdiDi>B-FI-DEN-402MH</basicUdiDi>
    <tradeName>Dengue IgG/IgM Test Cassette</tradeName>
    <deviceName>Dengue IgG/IgM Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-DEN-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:55.184Z</lastUpdated>
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    <udiDi>03573026608248</udiDi>
    <basicUdiDi>357302BUDI000627TU</basicUdiDi>
    <tradeName>VIDAS® Anti-DENGUE IgG</tradeName>
    <deviceName>VIDAS® Anti-DENGUE IgG</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423079</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:16.395Z</lastUpdated>
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    <udiDi>03573026608224</udiDi>
    <basicUdiDi>357302BUDI000626TS</basicUdiDi>
    <tradeName>VIDAS® Anti-DENGUE IgM</tradeName>
    <deviceName>VIDAS® Anti-DENGUE IgM</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423078</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:15.596Z</lastUpdated>
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    <udiDi>69743840309430</udiDi>
    <basicUdiDi>B-69743840309430</basicUdiDi>
    <tradeName>Dengue NS1 Antigen &amp; IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）</tradeName>
    <deviceName>Dengue NS1 Antigen &amp; IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</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>Artık piyasada değil</deviceStatus>
    <reference>3021303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:42.780Z</lastUpdated>
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    <udiDi>D-693757992103PY</udiDi>
    <basicUdiDi>B-693757992103PY</basicUdiDi>
    <tradeName>Dengue NS1/IgM/IgG test cassette</tradeName>
    <deviceName>Dengue NS1/IgM/IgG test cassette</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-NS1/IgM/IgG 252102</reference>
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    <lastUpdated>2026-07-17T00:49:19.277Z</lastUpdated>
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    <tradeName>Dengue NS1 antigen test cassette</tradeName>
    <deviceName>Dengue NS1 antigen test cassette</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <tradeName>Dengue IgM/IgG test cassette</tradeName>
    <deviceName>Dengue IgM/IgG test cassette</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Dengue-IgM/IgG 252102</reference>
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    <lastUpdated>2026-07-17T00:49:17.371Z</lastUpdated>
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    <udiDi>06974785750556</udiDi>
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    <tradeName>Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</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>IDEC-5023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:49.331Z</lastUpdated>
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    <tradeName>+ENTIRE586810M</tradeName>
    <deviceName>Dengue Virus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:08.533Z</lastUpdated>
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    <tradeName>+ENTIRE586710L</tradeName>
    <deviceName>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>RE58671</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:07.736Z</lastUpdated>
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