<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970277515719</udiDi>
    <basicUdiDi>B-06970277515719</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICOV-502</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:39:06.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970277513340</udiDi>
    <basicUdiDi>B-06970277513340</basicUdiDi>
    <tradeName>06970277513340</tradeName>
    <deviceName>Norovirus/Rotavirus/Adenovirus Combo Rapid 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INRA-635</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:38:21.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970277513302</udiDi>
    <basicUdiDi>B-06970277513302</basicUdiDi>
    <tradeName>Norovirus Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Norovirus Rapid Test Cassette (Feces)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INO-602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:38:20.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970221768963</udiDi>
    <basicUdiDi>B-06970221768963</basicUdiDi>
    <tradeName>SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test</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>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISIRA-757</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:36:01.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970221768956</udiDi>
    <basicUdiDi>B-06970221768956</basicUdiDi>
    <tradeName>SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test</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>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISIR-737</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:36:00.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970221768949</udiDi>
    <basicUdiDi>B-06970221768949</basicUdiDi>
    <tradeName>SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test</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>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISIR-737</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:59.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730731</udiDi>
    <basicUdiDi>B-06955792730731</basicUdiDi>
    <tradeName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</tradeName>
    <deviceName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3362E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:51.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730724</udiDi>
    <basicUdiDi>B-06955792730724</basicUdiDi>
    <tradeName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</tradeName>
    <deviceName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3362E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:47.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730717</udiDi>
    <basicUdiDi>B-06955792730717</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:45.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730700</udiDi>
    <basicUdiDi>B-06955792730700</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3357E-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:42.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730694</udiDi>
    <basicUdiDi>B-06955792730694</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3357E-5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:40.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730687</udiDi>
    <basicUdiDi>B-06955792730687</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3357E-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:36.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730670</udiDi>
    <basicUdiDi>B-06955792730670</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3355E-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:34.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730663</udiDi>
    <basicUdiDi>B-06955792730663</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3355E-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:33.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730656</udiDi>
    <basicUdiDi>B-06955792730656</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3355E-5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:31.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730649</udiDi>
    <basicUdiDi>B-06955792730649</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S3355E-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:27.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804832469</udiDi>
    <basicUdiDi>69528048A4A23005D</basicUdiDi>
    <tradeName>Rotavirus and Adenovirus Combo Rapid Test</tradeName>
    <deviceName>Rotavirus and Adenovirus Combo Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4A230</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:33:45.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804832087</udiDi>
    <basicUdiDi>69528048A4791503Y</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Format (cassette):  A47915; Format (pen):  A48410</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:33:28.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804811129</udiDi>
    <basicUdiDi>69528048A4B27106F</basicUdiDi>
    <tradeName>Norovirus GI+GII Rapid Test</tradeName>
    <deviceName>Norovirus GI+GII Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4B271</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:14.732Z</lastUpdated>
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  <row>
    <udiDi>06952804809850</udiDi>
    <basicUdiDi>B-06952804809850</basicUdiDi>
    <tradeName>06952804809850</tradeName>
    <deviceName>Adenovirus Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:26:55.650Z</lastUpdated>
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</eudamedExport>