<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05032384503827</udiDi>
    <basicUdiDi>5032384ImagenHSVVJ</basicUdiDi>
    <tradeName>IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPE 1 and 2</tradeName>
    <deviceName>IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPE 1 and 2</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K610611-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:07.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080500003</udiDi>
    <basicUdiDi>50560805PathoDXHerpesW5</basicUdiDi>
    <tradeName>PATHODX HERPES TYPING KIT</tradeName>
    <deviceName>PATHODX HERPES TYPING KIT</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:50.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISAB-425EM</udiDi>
    <basicUdiDi>B-ISAB-425EM</basicUdiDi>
    <tradeName>HSV 1/2 IgG/IgM Combo Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 IgG/IgM Combo Rapid Test Cassette</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>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISAB-425</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:36.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974473303804</udiDi>
    <basicUdiDi>B-06974473303804</basicUdiDi>
    <tradeName>HSV 12 Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>HSV 12 Antigen Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:54.287Z</lastUpdated>
  </row>
</eudamedExport>