<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SC20201W-1TZJ</udiDi>
    <basicUdiDi>B-SC20201W-1TZJ</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20201W-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:40.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20101W-50TVD</udiDi>
    <basicUdiDi>B-SC20101W-50TVD</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20101W-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:33.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20101W-25TVD</udiDi>
    <basicUdiDi>B-SC20101W-25TVD</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20101W-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:31.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20101W-20TUW</udiDi>
    <basicUdiDi>B-SC20101W-20TUW</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20101W-20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:29.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC20101W-1TYZ</udiDi>
    <basicUdiDi>B-SC20101W-1TYZ</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Kit</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC20101W-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:27.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC10101W-25TUG</udiDi>
    <basicUdiDi>B-SC10101W-25TUG</basicUdiDi>
    <tradeName>Influenza A&amp;B Rapid Test Kit</tradeName>
    <deviceName>Influenza A&amp;B Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</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>SC10101W-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:27.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC10101W-50TUG</udiDi>
    <basicUdiDi>B-SC10101W-50TUG</basicUdiDi>
    <tradeName>Influenza A&amp;B Rapid Test Kit</tradeName>
    <deviceName>Influenza A&amp;B Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</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>SC10101W-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:25.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC10101W-1TYA</udiDi>
    <basicUdiDi>B-SC10101W-1TYA</basicUdiDi>
    <tradeName>Influenza A&amp;B Rapid Test Kit</tradeName>
    <deviceName>Influenza A&amp;B Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</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>SC10101W-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:23.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SC10101W-20TTZ</udiDi>
    <basicUdiDi>B-SC10101W-20TTZ</basicUdiDi>
    <tradeName>Influenza A&amp;B Rapid Test Kit</tradeName>
    <deviceName>Influenza A&amp;B Rapid Test Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</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>.SC10101W-20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:38:21.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RSV-B02bTT</udiDi>
    <basicUdiDi>B-RSV-B02bTT</basicUdiDi>
    <tradeName>Respiratory Syncytial Virus (RSV) Antigen Rapid Test</tradeName>
    <deviceName>Respiratory Syncytial Virus (RSV) Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSV-B02b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:39.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ROTA-F02aKZ</udiDi>
    <basicUdiDi>B-ROTA-F02aKZ</basicUdiDi>
    <tradeName>Rotavirus Antigen Rapid Test</tradeName>
    <deviceName>Rotavirus Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>ROTA-F02a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:03.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RHV-2-EZW</udiDi>
    <basicUdiDi>B-RHV-2-EZW</basicUdiDi>
    <tradeName>Rhinovirus Rapid Test Cassette</tradeName>
    <deviceName>Rhinovirus Rapid Test Cassette</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHV-2-E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:37.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA010UC</udiDi>
    <basicUdiDi>B-RA010UC</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>POC SARS-CoV-2 Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122-05024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:47.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440201441</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AD5W</basicUdiDi>
    <tradeName>CerTest Adenovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD820001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:50:15.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207320</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AD5W</basicUdiDi>
    <tradeName>CerTest Adenovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD820001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:50:08.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OF02-COV6F</udiDi>
    <basicUdiDi>B-OF02-COV6F</basicUdiDi>
    <tradeName>D-OF02-COV6F</tradeName>
    <deviceName>SARS-CoV-2 Ag Test</deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OF02-COV</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:15.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NOV-F02aQ5</udiDi>
    <basicUdiDi>B-NOV-F02aQ5</basicUdiDi>
    <tradeName>Norovirus Antigen Rapid Test</tradeName>
    <deviceName>Norovirus Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOV-F02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:24:07.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90507ZK</udiDi>
    <basicUdiDi>B-K90507ZK</basicUdiDi>
    <tradeName>D-K90507ZK</tradeName>
    <deviceName>Influenza A&amp;B Antigen Test kit(Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</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>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:27.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD53-02-50tBT</udiDi>
    <basicUdiDi>B-IVD53-02-50tBT</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>FLU A/B Antigen Test Kit（Colloidal Gold ）</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>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD53-02-50t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:25.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD53-02-20tBC</udiDi>
    <basicUdiDi>B-IVD53-02-20tBC</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>FLU A/B Antigen Test Kit（Colloidal Gold ）</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>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD53-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:23.781Z</lastUpdated>
  </row>
</eudamedExport>