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    <basicUdiDi>B-00628347561604</basicUdiDi>
    <tradeName>Artron Dengue NS1 Antigen Test</tradeName>
    <deviceName>Dengue NS1 Antigen Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</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>A03-22-222</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:57.458Z</lastUpdated>
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    <udiDi>D-000041242DEN003-256L</udiDi>
    <basicUdiDi>B-000041242DEN003-256L</basicUdiDi>
    <tradeName>D-000041242DEN003-256L</tradeName>
    <deviceName>Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN003-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:41.353Z</lastUpdated>
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    <udiDi>D-000041242DEN003-056E</udiDi>
    <basicUdiDi>B-000041242DEN003-056E</basicUdiDi>
    <tradeName>D-000041242DEN003-056E</tradeName>
    <deviceName>Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN003-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:38.944Z</lastUpdated>
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    <udiDi>D-000041242DEN003-0166</udiDi>
    <basicUdiDi>B-000041242DEN003-0166</basicUdiDi>
    <tradeName>D-000041242DEN003-0166</tradeName>
    <deviceName>Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN003-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:37.350Z</lastUpdated>
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    <udiDi>06972412613991</udiDi>
    <basicUdiDi>697241261IDE-A402EJ</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Dengue IgG/IgM Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-A402-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:54:11.740Z</lastUpdated>
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    <udiDi>05902643958630</udiDi>
    <basicUdiDi>59026439BRT355JV</basicUdiDi>
    <tradeName>05902643958630</tradeName>
    <deviceName>Dengue Ab/Ag kasetki 20 szt.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-355-K020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:27:34.444Z</lastUpdated>
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    <basicUdiDi>59026439BRT354JT</basicUdiDi>
    <tradeName>05902643958623</tradeName>
    <deviceName>Dengue NS1 kasetki 20 szt.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-354-K020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:27:33.647Z</lastUpdated>
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    <basicUdiDi>59026439BRT353JR</basicUdiDi>
    <tradeName>05902643958616</tradeName>
    <deviceName>Dengue - kasetki 20 szt.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-353-K020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:27:32.842Z</lastUpdated>
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    <udiDi>08904226008869</udiDi>
    <basicUdiDi>8904226058IC104WS</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Crystal® Dengue IgG/IgM</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58IC104-25, 58IC104-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:46.105Z</lastUpdated>
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    <udiDi>08904226008845</udiDi>
    <basicUdiDi>8904226058IC106WW</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Crystal Dengue Duo</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58IC106-10, 58IC106-25, 58IC106-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:44.906Z</lastUpdated>
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    <udiDi>08904226008821</udiDi>
    <basicUdiDi>8904226058IC102WN</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Crystal Dengue NS1</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58IC102-10, 58IC102-25, 58IC102-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:43.709Z</lastUpdated>
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    <basicUdiDi>697241261IDE-4258Q</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1/IgG/IgM Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-425-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:31.575Z</lastUpdated>
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    <basicUdiDi>697241261IDE-B402ER</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-B402-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:30.381Z</lastUpdated>
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    <basicUdiDi>697241261IDE-B402ER</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
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    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-B402-05</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:23.291Z</lastUpdated>
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    <basicUdiDi>697241261IDE-4258Q</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1/IgG/IgM Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
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    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-425-05</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:20.774Z</lastUpdated>
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    <basicUdiDi>697241261IDE-B402ER</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
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    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-B402-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:19.590Z</lastUpdated>
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    <basicUdiDi>697241261IDE-4258Q</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1/IgG/IgM Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
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    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-425-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:12.430Z</lastUpdated>
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    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1/IgG/IgM Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
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    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-425-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:09.974Z</lastUpdated>
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    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
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    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:03:02.890Z</lastUpdated>
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    <tradeName>LYHER</tradeName>
    <deviceName>Dengue NS1 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
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    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-B402-40</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:02:53.172Z</lastUpdated>
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