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<eudamedExport entity="devices">
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    <udiDi>06940150032169</udiDi>
    <basicUdiDi>B-06940150032169</basicUdiDi>
    <tradeName>06940150032169</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Huasin Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029856</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DY080</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:18:59.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716400177</udiDi>
    <basicUdiDi>B-06939716400177</basicUdiDi>
    <tradeName>HOKAPI™ SARS-COV-2 NEUTRALIZING AB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010221101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:05:39.036Z</lastUpdated>
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  <row>
    <udiDi>06939663977876</udiDi>
    <basicUdiDi>B-06939663977876</basicUdiDi>
    <tradeName>Adenovirus Rapid Test (Feces)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:53.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663976800</udiDi>
    <basicUdiDi>B-06939663976800</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A+B Antigen Combo Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COIF-522</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:22.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663976107</udiDi>
    <basicUdiDi>B-06939663976107</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVG-602ST</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:21.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339206756</udiDi>
    <basicUdiDi>B-06937339206756</basicUdiDi>
    <tradeName>Rotavirus Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID123-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:54:20.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205063</udiDi>
    <basicUdiDi>B-06937339205063</basicUdiDi>
    <tradeName>VivaDiag Rotavirus/Adenovirus Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID112-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:42.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803842</udiDi>
    <basicUdiDi>B-06936155803842</basicUdiDi>
    <tradeName>W0105040601</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP14002-TC20</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:51.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803637</udiDi>
    <basicUdiDi>B-06936155803637</basicUdiDi>
    <tradeName>Rapid Rotavirus Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP14001-TC20</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:28.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208951</udiDi>
    <basicUdiDi>B-06933260208951</basicUdiDi>
    <tradeName>Flu A/B &amp; COVID-19 Ag Combo Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT1781</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:59.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208807</udiDi>
    <basicUdiDi>B-06933260208807</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Qualitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0201401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:50.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208791</udiDi>
    <basicUdiDi>B-06933260208791</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0200304</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:49.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208784</udiDi>
    <basicUdiDi>B-06933260208784</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0200303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:47.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208777</udiDi>
    <basicUdiDi>B-06933260208777</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0200302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:46.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208760</udiDi>
    <basicUdiDi>B-06933260208760</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0200301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:44.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208753</udiDi>
    <basicUdiDi>B-06933260208753</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0200201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:43.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208746</udiDi>
    <basicUdiDi>B-06933260208746</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0200101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:41.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208739</udiDi>
    <basicUdiDi>B-06933260208739</basicUdiDi>
    <tradeName>SARS-CoV-2 IgG/IgM Rapid Qualitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT1301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:40.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208104</udiDi>
    <basicUdiDi>B-06933260208104</basicUdiDi>
    <tradeName>Strep A Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0105501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:20.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208098</udiDi>
    <basicUdiDi>B-06933260208098</basicUdiDi>
    <tradeName>FluA/B&amp;ADV&amp;RSV Antigen Combo Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0105401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:19.586Z</lastUpdated>
  </row>
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