<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06928103002025</udiDi>
    <basicUdiDi>B-06928103002025</basicUdiDi>
    <tradeName>06928103002025</tradeName>
    <deviceName>Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:45.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002018</udiDi>
    <basicUdiDi>B-06928103002018</basicUdiDi>
    <tradeName>06928103002018</tradeName>
    <deviceName>Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:44.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002001</udiDi>
    <basicUdiDi>B-06928103002001</basicUdiDi>
    <tradeName>06928103002001</tradeName>
    <deviceName>Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:40.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103001530</udiDi>
    <basicUdiDi>B-06928103001530</basicUdiDi>
    <tradeName>06928103001530</tradeName>
    <deviceName>Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0153</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:38.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103001516</udiDi>
    <basicUdiDi>B-06928103001516</basicUdiDi>
    <tradeName>06928103001516</tradeName>
    <deviceName>Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:37.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103001509</udiDi>
    <basicUdiDi>B-06928103001509</basicUdiDi>
    <tradeName>06928103001509</tradeName>
    <deviceName>Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:32.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719878570022</udiDi>
    <basicUdiDi>B-04719878570022</basicUdiDi>
    <tradeName>VitaPCR Flu A&amp;B Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:40:26.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719878570169</udiDi>
    <basicUdiDi>B-04719878570169</basicUdiDi>
    <tradeName>VitaPCR SARS-CoV-2 Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:40:26.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719878570220</udiDi>
    <basicUdiDi>B-04719878570220</basicUdiDi>
    <tradeName>VitaPCR SARS-CoV-2 Gen 2 Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:40:26.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719878570541</udiDi>
    <basicUdiDi>B-04719878570541</basicUdiDi>
    <tradeName>VitaSIRO solo HPV Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAD1104/ PCRAD1114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:40:26.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574459</udiDi>
    <basicUdiDi>B-06925794574459</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HSV-I/II IgM Antibody Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1×100 test/kit R1:1×4mL R2:1×5mL R3:1×9mL	 Calibrator High value:1×1mL; L Calibrator Low value:1×1mL	 etc</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:38:48.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574442</udiDi>
    <basicUdiDi>B-06925794574442</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HSV-II IgG Antibody Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1×100 test/kit  etc</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:38:47.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963716927</udiDi>
    <basicUdiDi>B-06921963716927</basicUdiDi>
    <tradeName>Rapid Zika Virus IgG/IgM Combo Test Card</tradeName>
    <deviceName>Rapid Zika Virus IgG/IgM Combo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N28C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:42.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963716910</udiDi>
    <basicUdiDi>B-06921963716910</basicUdiDi>
    <tradeName>Rapid Chikungunya IgG/IgM Combo Test Card</tradeName>
    <deviceName>Rapid Chikungunya IgG/IgM Combo Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N27C2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:41.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712745</udiDi>
    <basicUdiDi>B-06921963712745</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-10 (for 20 Tests/Box)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:23.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712660</udiDi>
    <basicUdiDi>B-06921963712660</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:22.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712585</udiDi>
    <basicUdiDi>B-06921963712585</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:21.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712332</udiDi>
    <basicUdiDi>B-06921963712332</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</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>1N40C5-6 (20 Tests/Kit)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:17.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712264</udiDi>
    <basicUdiDi>B-06921963712264</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:16.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921963712257</udiDi>
    <basicUdiDi>B-06921963712257</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N40C5-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:58:15.995Z</lastUpdated>
  </row>
</eudamedExport>