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<eudamedExport entity="devices">
  <row>
    <udiDi>06925794574459</udiDi>
    <basicUdiDi>B-06925794574459</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HSV-I/II IgM Antibody Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1×100 test/kit R1:1×4mL R2:1×5mL R3:1×9mL	 Calibrator High value:1×1mL; L Calibrator Low value:1×1mL	 etc</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:38:48.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574442</udiDi>
    <basicUdiDi>B-06925794574442</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HSV-II IgG Antibody Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1×100 test/kit  etc</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:38:47.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794518880</udiDi>
    <basicUdiDi>B-06925794518880</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3010684</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:07.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794518873</udiDi>
    <basicUdiDi>B-06925794518873</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3010664</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:35:01.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963723277</udiDi>
    <basicUdiDi>B-06921963723277</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Test Card</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N42C2</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:59:34.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963719935</udiDi>
    <basicUdiDi>B-06921963719935</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N44C5</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:59:33.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963717122</udiDi>
    <basicUdiDi>B-06921963717122</basicUdiDi>
    <tradeName>Rapid Legionella Urinary Antigen Test Card</tradeName>
    <deviceName>Rapid Legionella Urinary Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1O05C3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:59:28.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963717115</udiDi>
    <basicUdiDi>B-06921963717115</basicUdiDi>
    <tradeName>Rapid HEV IgG/IgM Combo Test Card</tradeName>
    <deviceName>Rapid HEV IgG/IgM Combo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1H26C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:59:26.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963716927</udiDi>
    <basicUdiDi>B-06921963716927</basicUdiDi>
    <tradeName>Rapid Zika Virus IgG/IgM Combo Test Card</tradeName>
    <deviceName>Rapid Zika Virus IgG/IgM Combo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N28C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:42.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963716910</udiDi>
    <basicUdiDi>B-06921963716910</basicUdiDi>
    <tradeName>Rapid Chikungunya IgG/IgM Combo Test Card</tradeName>
    <deviceName>Rapid Chikungunya IgG/IgM Combo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N27C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:41.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963715982</udiDi>
    <basicUdiDi>B-06921963715982</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N45C5-1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:37.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963716637</udiDi>
    <basicUdiDi>B-06921963716637</basicUdiDi>
    <tradeName>Rapid V.Cholerae O1/O139 Duo Test Card</tradeName>
    <deviceName>Rapid V.Cholerae O1/O139 Duo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1O17C4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:36.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963715913</udiDi>
    <basicUdiDi>B-06921963715913</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N41C5-25</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:35.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963715364</udiDi>
    <basicUdiDi>B-06921963715364</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N45C5</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:33.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963715357</udiDi>
    <basicUdiDi>B-06921963715357</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N41C5-27</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:33.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963715272</udiDi>
    <basicUdiDi>B-06921963715272</basicUdiDi>
    <tradeName>Rapid HAV IgG/IgM Combo Test Card</tradeName>
    <deviceName>Rapid HAV IgG/IgM Combo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1H16C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:28.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712745</udiDi>
    <basicUdiDi>B-06921963712745</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-10 (for 20 Tests/Box)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:23.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712660</udiDi>
    <basicUdiDi>B-06921963712660</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:22.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712585</udiDi>
    <basicUdiDi>B-06921963712585</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:21.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712332</udiDi>
    <basicUdiDi>B-06921963712332</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-6 (20 Tests/Kit)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:17.585Z</lastUpdated>
  </row>
</eudamedExport>