<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-1R10EE</udiDi>
    <basicUdiDi>B-1R10EE</basicUdiDi>
    <tradeName>mariPOC® Parainfluenza virus 3 test reagent</tradeName>
    <deviceName>mariPOC® Parainfluenza virus 3 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R10</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:11.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R09EV</udiDi>
    <basicUdiDi>B-1R09EV</basicUdiDi>
    <tradeName>mariPOC® Parainfluenza virus 2 test reagent</tradeName>
    <deviceName>mariPOC® Parainfluenza virus 2 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R09</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:10.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R08ET</udiDi>
    <basicUdiDi>B-1R08ET</basicUdiDi>
    <tradeName>mariPOC® Parainfluenza virus 1 test reagent</tradeName>
    <deviceName>mariPOC® Parainfluenza virus 1 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R08</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:18:01.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R07ER</udiDi>
    <basicUdiDi>B-1R07ER</basicUdiDi>
    <tradeName>mariPOC® Influenza B virus test reagent</tradeName>
    <deviceName>mariPOC® Influenza B virus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R07</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:18:01.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R06EP</udiDi>
    <basicUdiDi>B-1R06EP</basicUdiDi>
    <tradeName>mariPOC® Influenza A virus test reagent</tradeName>
    <deviceName>mariPOC® Influenza A virus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R06</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:59.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R05EM</udiDi>
    <basicUdiDi>B-1R05EM</basicUdiDi>
    <tradeName>mariPOC® Human metapneumovirus test reagent</tradeName>
    <deviceName>mariPOC® Human metapneumovirus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040617</emdnCode>
    <emdnDescription>HUMAN METAPNEUMOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R05</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:56.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R04EK</udiDi>
    <basicUdiDi>B-1R04EK</basicUdiDi>
    <tradeName>mariPOC® Human coronavirus OC43 test reagent</tradeName>
    <deviceName>mariPOC® Human coronavirus OC43 test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R04</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:55.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R03EH</udiDi>
    <basicUdiDi>B-1R03EH</basicUdiDi>
    <tradeName>mariPOC® Human bocavirus test reagent</tradeName>
    <deviceName>mariPOC® Human bocavirus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040618</emdnCode>
    <emdnDescription>BOCAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R03</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:55.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1R01ED</udiDi>
    <basicUdiDi>B-1R01ED</basicUdiDi>
    <tradeName>mariPOC® Adenovirus respiratory test reagent</tradeName>
    <deviceName>mariPOC® Adenovirus respiratory test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R01</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:50.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036043135</udiDi>
    <basicUdiDi>B-18594036043135</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-TBEV IgG avidity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-313-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:54.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036043111</udiDi>
    <basicUdiDi>B-18594036043111</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-TBEV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-311-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:48.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036043104</udiDi>
    <basicUdiDi>B-18594036043104</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-TBEV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-310-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:48.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974198355017</udiDi>
    <basicUdiDi>B-16974198355017</basicUdiDi>
    <tradeName>16974198355017</tradeName>
    <deviceName>SARS-Cov-2 Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Higene Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000029811</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>nCoVAG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:04:29.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974198354010</udiDi>
    <basicUdiDi>B-16974198354010</basicUdiDi>
    <tradeName>16974198354010</tradeName>
    <deviceName>SARS-Cov-2 Antigen FLU A+B Antigen combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Higene Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000029811</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>nCoFLu</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:04:29.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974198352016</udiDi>
    <basicUdiDi>B-16974198352016</basicUdiDi>
    <tradeName>16974198352016</tradeName>
    <deviceName>SARS-Cov-2(covid-19)IgMIgG Antibody Fast Detection Kit（Colloidal Gold）</deviceName>
    <manufacturerName>Hangzhou Higene Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000029811</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>NCoV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:04:27.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974198351019</udiDi>
    <basicUdiDi>B-16974198351019</basicUdiDi>
    <tradeName>16974198351019</tradeName>
    <deviceName>Real-time PCR Kit for Rapid Detection of SARS-COV-2</deviceName>
    <manufacturerName>Hangzhou Higene Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000029811</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>nCoV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:04:23.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601351</udiDi>
    <basicUdiDi>B-16972698601351</basicUdiDi>
    <tradeName>Strep A Antigen Rapid Test</tradeName>
    <deviceName>Strep A Antigen 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>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211116</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:13.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972235840038</udiDi>
    <basicUdiDi>B-16972235840038</basicUdiDi>
    <tradeName>COVID-19/FluA/FluB Antigen Detection Kit(Colloidal Gold)</tradeName>
    <deviceName>COVID-19/FluA/FluB Antigen Detection Kit(Colloidal Gold)</deviceName>
    <manufacturerName>Zhuhai Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026852</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LCV07</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:04.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763143</udiDi>
    <basicUdiDi>B-15065023763143</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Rotavirus Rapid Test (LFA)</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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:15.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763075</udiDi>
    <basicUdiDi>B-15065023763075</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>ADV Antigen Rapid Test (LFA)</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>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:03.330Z</lastUpdated>
  </row>
</eudamedExport>