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<eudamedExport entity="devices">
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    <udiDi>06977903342428</udiDi>
    <basicUdiDi>B-06977903342428</basicUdiDi>
    <tradeName>06977903342428</tradeName>
    <deviceName>Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110103C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:22.333Z</lastUpdated>
  </row>
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    <udiDi>06977903342411</udiDi>
    <basicUdiDi>B-06977903342411</basicUdiDi>
    <tradeName>06977903342411</tradeName>
    <deviceName>Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110103C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:21.528Z</lastUpdated>
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  <row>
    <udiDi>06977903342329</udiDi>
    <basicUdiDi>B-06977903342329</basicUdiDi>
    <tradeName>06977903342329</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) Antigen Testing Kit</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110102C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:19.935Z</lastUpdated>
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  <row>
    <udiDi>06977903342312</udiDi>
    <basicUdiDi>B-06977903342312</basicUdiDi>
    <tradeName>06977903342312</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) Antigen Testing Kit</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110102C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:17.524Z</lastUpdated>
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  <row>
    <udiDi>06977903342220</udiDi>
    <basicUdiDi>B-06977903342220</basicUdiDi>
    <tradeName>06977903342220</tradeName>
    <deviceName>Troponin I/Myoglobin/CK-MB Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110603C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:15.929Z</lastUpdated>
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  <row>
    <udiDi>06977903342213</udiDi>
    <basicUdiDi>B-06977903342213</basicUdiDi>
    <tradeName>06977903342213</tradeName>
    <deviceName>Troponin I/Myoglobin/CK-MB Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110603C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:15.125Z</lastUpdated>
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  <row>
    <udiDi>06977903342121</udiDi>
    <basicUdiDi>B-06977903342121</basicUdiDi>
    <tradeName>06977903342121</tradeName>
    <deviceName>Rotavirus Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110504C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:13.528Z</lastUpdated>
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  <row>
    <udiDi>06977903342114</udiDi>
    <basicUdiDi>B-06977903342114</basicUdiDi>
    <tradeName>06977903342114</tradeName>
    <deviceName>Rotavirus Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110504C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:11.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903342022</udiDi>
    <basicUdiDi>B-06977903342022</basicUdiDi>
    <tradeName>06977903342022</tradeName>
    <deviceName>Adenovirus Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110505C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:09.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903342015</udiDi>
    <basicUdiDi>B-06977903342015</basicUdiDi>
    <tradeName>06977903342015</tradeName>
    <deviceName>Adenovirus Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110505C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:08.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903341926</udiDi>
    <basicUdiDi>B-06977903341926</basicUdiDi>
    <tradeName>06977903341926</tradeName>
    <deviceName>Rota/Adeno Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110506C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:07.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903341919</udiDi>
    <basicUdiDi>B-06977903341919</basicUdiDi>
    <tradeName>06977903341919</tradeName>
    <deviceName>Rota/Adeno Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110506C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:04.719Z</lastUpdated>
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  <row>
    <udiDi>06977903341827</udiDi>
    <basicUdiDi>B-06977903341827</basicUdiDi>
    <tradeName>06977903341827</tradeName>
    <deviceName>Malaria Pf/Pv Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110401C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:03.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903341810</udiDi>
    <basicUdiDi>B-06977903341810</basicUdiDi>
    <tradeName>06977903341810</tradeName>
    <deviceName>Malaria Pf/Pv Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110401C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:02.345Z</lastUpdated>
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  <row>
    <udiDi>06977903341728</udiDi>
    <basicUdiDi>B-06977903341728</basicUdiDi>
    <tradeName>06977903341728</tradeName>
    <deviceName>Influenza A/B Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110106C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:00.713Z</lastUpdated>
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  <row>
    <udiDi>06977903341711</udiDi>
    <basicUdiDi>B-06977903341711</basicUdiDi>
    <tradeName>06977903341711</tradeName>
    <deviceName>Influenza A/B Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110106C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:58.458Z</lastUpdated>
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    <udiDi>06977903341612</udiDi>
    <basicUdiDi>B-06977903341612</basicUdiDi>
    <tradeName>06977903341612</tradeName>
    <deviceName>COVID-19/Flu A/Flu B Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110105C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:56.712Z</lastUpdated>
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  <row>
    <udiDi>06977903341629</udiDi>
    <basicUdiDi>B-06977903341629</basicUdiDi>
    <tradeName>06977903341629</tradeName>
    <deviceName>COVID-19/Flu A/Flu B Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110105C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:55.910Z</lastUpdated>
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  <row>
    <udiDi>06977903341513</udiDi>
    <basicUdiDi>B-06977903341513</basicUdiDi>
    <tradeName>06977903341513</tradeName>
    <deviceName>COVID-19 Ag Lollypop Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110101C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:54.576Z</lastUpdated>
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  <row>
    <udiDi>06977903341520</udiDi>
    <basicUdiDi>B-06977903341520</basicUdiDi>
    <tradeName>06977903341520</tradeName>
    <deviceName>COVID-19 Ag Lollypop Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110101C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:52.025Z</lastUpdated>
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</eudamedExport>