<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-808152-1AX</udiDi>
    <basicUdiDi>B-808152-1AX</basicUdiDi>
    <tradeName>D-808152-1AX</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808152-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:32.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>37700267940128</udiDi>
    <basicUdiDi>B-37700267940128</basicUdiDi>
    <tradeName>SirYus Covidiag +</tradeName>
    <deviceName>SirYus Covidiag +</deviceName>
    <manufacturerName>Innobiochips</manufacturerName>
    <manufacturerSrn>FR-MF-000009584</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2009</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:50:49.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>37700267940050</udiDi>
    <basicUdiDi>B-37700267940050</basicUdiDi>
    <tradeName>SirYus Covidiag</tradeName>
    <deviceName>SirYus Covidiag</deviceName>
    <manufacturerName>Innobiochips</manufacturerName>
    <manufacturerSrn>FR-MF-000009584</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:50:33.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2027MGT</udiDi>
    <basicUdiDi>B-2027MGT</basicUdiDi>
    <tradeName>mariPOC® Gastro CDI combi test plate</tradeName>
    <deviceName>mariPOC® Gastro CDI combi test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2027M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:04.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2017MGN</udiDi>
    <basicUdiDi>B-2017MGN</basicUdiDi>
    <tradeName>mariPOC® Gastro test plate</tradeName>
    <deviceName>mariPOC® Gastro test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2017M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:55.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698604123</udiDi>
    <basicUdiDi>B-16972698604123</basicUdiDi>
    <tradeName>Candida albicans /Gardnerella vaginalis/Trichomonas vaginalis antigen Combo  Rapid Test</tradeName>
    <deviceName>Candida albicans /Gardnerella vaginalis/Trichomonas vaginalis antigen Combo  Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P271102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:59.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601375</udiDi>
    <basicUdiDi>B-16972698601375</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Flu &amp; RSV &amp; ADV Antigen Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 &amp; Flu &amp; RSV &amp; ADV Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211145</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:18.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601368</udiDi>
    <basicUdiDi>B-16972698601368</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Flu &amp; RSV Antigen Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 &amp; Flu &amp; RSV Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211144</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:14.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600835</udiDi>
    <basicUdiDi>B-16972698600835</basicUdiDi>
    <tradeName>Flu &amp; COVID-19 Antigen Combo Rapid Test</tradeName>
    <deviceName>Flu &amp; COVID-19 Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P213110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:29.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600828</udiDi>
    <basicUdiDi>B-16972698600828</basicUdiDi>
    <tradeName>EZER Flu &amp; COVID-19 Antigen Duo Rapid Test</tradeName>
    <deviceName>EZER Flu &amp; COVID-19 Antigen Duo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P213109</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:28.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600811</udiDi>
    <basicUdiDi>B-16972698600811</basicUdiDi>
    <tradeName>EZER Flu &amp; COVID-19 Antigen Duo Rapid Test</tradeName>
    <deviceName>EZER Flu &amp; COVID-19 Antigen Duo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P213107</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:27.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600804</udiDi>
    <basicUdiDi>B-16972698600804</basicUdiDi>
    <tradeName>EZER Flu &amp; COVID-19 Antigen Duo Rapid Test</tradeName>
    <deviceName>EZER Flu &amp; COVID-19 Antigen Duo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P213106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:23.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600606</udiDi>
    <basicUdiDi>B-16972698600606</basicUdiDi>
    <tradeName>Flu &amp; COVID-19 Antigen Duo Rapid Test</tradeName>
    <deviceName>Flu &amp; COVID-19 Antigen Duo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211137</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:51:09.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600132</udiDi>
    <basicUdiDi>B-16972698600132</basicUdiDi>
    <tradeName>Rotavirus / ADV Antigen Rapid Test Device</tradeName>
    <deviceName>Rotavirus / ADV Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221104</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:44.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600118</udiDi>
    <basicUdiDi>B-16972698600118</basicUdiDi>
    <tradeName>ADV/RSV Antigen Rapid Test Device</tradeName>
    <deviceName>ADV/RSV Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P212106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:24.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245349</udiDi>
    <basicUdiDi>B-15065026245349</basicUdiDi>
    <tradeName>TruDerma</tradeName>
    <deviceName>Dermatophyte PCR Test Kit</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM10002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:38:04.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763372</udiDi>
    <basicUdiDi>B-15065023763372</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Bacterial Vaginosis Six Combo-Test Kit</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10038</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:06.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1214MGG</udiDi>
    <basicUdiDi>B-1214MGG</basicUdiDi>
    <tradeName>mariPOC® Quick combi+ test plate</tradeName>
    <deviceName>mariPOC® Quick combi+ test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1214M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:14.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1194MHH</udiDi>
    <basicUdiDi>B-1194MHH</basicUdiDi>
    <tradeName>mariPOC® RTI combi+ test plate</tradeName>
    <deviceName>mariPOC® RTI combi+ test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1194M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:12.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1184MHC</udiDi>
    <basicUdiDi>B-1184MHC</basicUdiDi>
    <tradeName>mariPOC® Respi+ test plate</tradeName>
    <deviceName>mariPOC® Respi+ test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1184M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:11.291Z</lastUpdated>
  </row>
</eudamedExport>