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<eudamedExport entity="devices">
  <row>
    <udiDi>D-R208152J</udiDi>
    <basicUdiDi>B-R208152J</basicUdiDi>
    <tradeName>D-R208152J</tradeName>
    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20815</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:25.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R208122C</udiDi>
    <basicUdiDi>B-R208122C</basicUdiDi>
    <tradeName>D-R208122C</tradeName>
    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20812</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:20.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R208112A</udiDi>
    <basicUdiDi>B-R208112A</basicUdiDi>
    <tradeName>D-R208112A</tradeName>
    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:20.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974677690335</udiDi>
    <basicUdiDi>B-06974677690335</basicUdiDi>
    <tradeName>Diagnostic Kit for 2019-nCoVIgM/lgG Antibody (Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for 2019-nCoVIgM/lgG Antibody (Colloidal Gold)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZC-MY-202-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:06.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974677690328</udiDi>
    <basicUdiDi>B-06974677690328</basicUdiDi>
    <tradeName>Diagnostic Kit for 2019-nCoVIgM/lgG Antibody (Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZC-MY-202-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:02.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006294</udiDi>
    <basicUdiDi>B-04050598006294</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgM ELISA</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgM ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 5001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:26.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581740</udiDi>
    <basicUdiDi>697518250P118026N</basicUdiDi>
    <tradeName>2019-nCoV IgM Antibody Determination Kit</tradeName>
    <deviceName>2019-nCoV IgM Antibody Determination Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11802</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:40.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020111997</udiDi>
    <basicUdiDi>B-06936020111997</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>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:08:43.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020111768</udiDi>
    <basicUdiDi>B-06936020111768</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>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD48-02-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:08:36.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020111751</udiDi>
    <basicUdiDi>B-06936020111751</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>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD48-02-5t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:08:35.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020111744</udiDi>
    <basicUdiDi>B-06936020111744</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>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD48-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:08:34.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020111737</udiDi>
    <basicUdiDi>B-06936020111737</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>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD48-02-1t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:08:32.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020111614</udiDi>
    <basicUdiDi>B-06936020111614</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>W0105041104</emdnCode>
    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD46-02-1t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:08:22.084Z</lastUpdated>
  </row>
</eudamedExport>