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<eudamedExport entity="devices">
  <row>
    <udiDi>04050598002548</udiDi>
    <basicUdiDi>B-04050598002548</basicUdiDi>
    <tradeName>MutaPLEX® FSME, PCR</tradeName>
    <deviceName>MutaPLEX® FSME, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1916096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:46.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>07073097800856</udiDi>
    <basicUdiDi>7073097KOPVIRTRA01G9</basicUdiDi>
    <tradeName>Virus transportmedium</tradeName>
    <deviceName>Virus transportmedium</deviceName>
    <manufacturerName>Oslo universitetssykehus HF</manufacturerName>
    <manufacturerSrn>NO-MF-000028214</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Not applicable</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:13:32.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260032</udiDi>
    <basicUdiDi>4049095ZN10040000S4</basicUdiDi>
    <tradeName>04049095260032</tradeName>
    <deviceName>RIDA®QUICK Rotavirus/Adenovirus Sample Diluent</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZN1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:57.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827144</udiDi>
    <basicUdiDi>B-06952804827144</basicUdiDi>
    <tradeName>E. histolytica &amp; Giardia lamblia &amp; Crypto Combo Rapid Test Kit</tradeName>
    <deviceName>E. histolytica &amp; Giardia lamblia &amp; Crypto Combo Rapid Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-F43001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:52.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827137</udiDi>
    <basicUdiDi>B-06952804827137</basicUdiDi>
    <tradeName>FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device</tradeName>
    <deviceName>FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-S45001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:48.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827090</udiDi>
    <basicUdiDi>B-06952804827090</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test</tradeName>
    <deviceName>Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-F44001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:35.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827083</udiDi>
    <basicUdiDi>B-06952804827083</basicUdiDi>
    <tradeName>Rotavirus-Adenovirus-Norovirus Combo test</tradeName>
    <deviceName>Rotavirus-Adenovirus-Norovirus Combo test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI-F43003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:32.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950917930102</udiDi>
    <basicUdiDi>B-06950917930102</basicUdiDi>
    <tradeName>06950917930102</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Triplex International Biosciences (China) Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001097</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C011906</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:27:12.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950917930089</udiDi>
    <basicUdiDi>B-06950917930089</basicUdiDi>
    <tradeName>06950917930089</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Triplex International Biosciences (China) Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001097</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C011909</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:27:11.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950917930065</udiDi>
    <basicUdiDi>B-06950917930065</basicUdiDi>
    <tradeName>06950917930065</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Triplex International Biosciences (China) Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001097</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C011907</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:27:05.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950917910609</udiDi>
    <basicUdiDi>B-06950917910609</basicUdiDi>
    <tradeName>06950917910609</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescent Probe)</deviceName>
    <manufacturerName>Triplex International Biosciences (China) Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001097</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C011942</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:27:03.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020115063</udiDi>
    <basicUdiDi>B-06936020115063</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD60-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:34.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020115056</udiDi>
    <basicUdiDi>B-06936020115056</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD60-02-1t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:32.920Z</lastUpdated>
  </row>
</eudamedExport>