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<eudamedExport entity="devices">
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    <udiDi>06928103005309</udiDi>
    <basicUdiDi>B-06928103005309</basicUdiDi>
    <tradeName>06928103005309</tradeName>
    <deviceName>HPV (6/11 genotypes) DNA TEST (Real-Time PCR)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:29:11.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003404</udiDi>
    <basicUdiDi>B-06928103003404</basicUdiDi>
    <tradeName>06928103003404</tradeName>
    <deviceName>Detection Kit for Severe Fever with Thrombocytopenia Syndrome Bunyavirus (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040514</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:29:10.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003220</udiDi>
    <basicUdiDi>B-06928103003220</basicUdiDi>
    <tradeName>06928103003220</tradeName>
    <deviceName>Detection Kit for Enterovirus 71/Coxsackievirus A16/Enterovirus 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>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:29:06.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003213</udiDi>
    <basicUdiDi>B-06928103003213</basicUdiDi>
    <tradeName>06928103003213</tradeName>
    <deviceName>Detection Kit for Enterovirus 71/Coxsackievirus A16/Enterovirus 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>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:29:05.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003206</udiDi>
    <basicUdiDi>B-06928103003206</basicUdiDi>
    <tradeName>06928103003206</tradeName>
    <deviceName>Detection Kit for Enterovirus 71/Coxsackievirus A16/Enterovirus 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>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:29:05.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003121</udiDi>
    <basicUdiDi>B-06928103003121</basicUdiDi>
    <tradeName>06928103003121</tradeName>
    <deviceName>Diagnostic Kit for Dengue Virus RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0312</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:29:04.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003114</udiDi>
    <basicUdiDi>B-06928103003114</basicUdiDi>
    <tradeName>06928103003114</tradeName>
    <deviceName>Diagnostic Kit for Dengue Virus RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0311</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:29:00.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003107</udiDi>
    <basicUdiDi>B-06928103003107</basicUdiDi>
    <tradeName>06928103003107</tradeName>
    <deviceName>Diagnostic Kit for Dengue Virus RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:59.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103003008</udiDi>
    <basicUdiDi>B-06928103003008</basicUdiDi>
    <tradeName>06928103003008</tradeName>
    <deviceName>Diagnostic Kit for Human Influenza Virus Subtype H3 RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:58.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002902</udiDi>
    <basicUdiDi>B-06928103002902</basicUdiDi>
    <tradeName>06928103002902</tradeName>
    <deviceName>Diagnostic Kit for Human Influenza Virus Subtype H1 RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0290</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:57.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002704</udiDi>
    <basicUdiDi>B-06928103002704</basicUdiDi>
    <tradeName>06928103002704</tradeName>
    <deviceName>Diagnostic Kit for Coxsackievirus A16 RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0270</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:53.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002605</udiDi>
    <basicUdiDi>B-06928103002605</basicUdiDi>
    <tradeName>06928103002605</tradeName>
    <deviceName>Diagnostic Kit for Enterovirus RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0260</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:52.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002407</udiDi>
    <basicUdiDi>B-06928103002407</basicUdiDi>
    <tradeName>06928103002407</tradeName>
    <deviceName>Diagnostic Kit for Human Influenza Virus B RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:51.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002308</udiDi>
    <basicUdiDi>B-06928103002308</basicUdiDi>
    <tradeName>06928103002308</tradeName>
    <deviceName>Diagnostic Kit for Human Influenza Virus A RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:50.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002209</udiDi>
    <basicUdiDi>B-06928103002209</basicUdiDi>
    <tradeName>06928103002209</tradeName>
    <deviceName>Detection Kit for Influenza A Virus H1N1 (IVA H1N1) (2009) RNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA0220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:46.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103002032</udiDi>
    <basicUdiDi>B-06928103002032</basicUdiDi>
    <tradeName>06928103002032</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>DA0203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T09:28:46.022Z</lastUpdated>
  </row>
  <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>
</eudamedExport>