<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DEAB/DEAG-D35aTS</udiDi>
    <basicUdiDi>B-DEAB/DEAG-D35aTS</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Combo Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM/NS1 Combo 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>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEAB/DEAG-D35a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:37.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEAB-D02aRS</udiDi>
    <basicUdiDi>B-DEAB-D02aRS</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM 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>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEAB-D02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:37.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-FIASTD25UB</udiDi>
    <basicUdiDi>B-D-FIASTD25UB</basicUdiDi>
    <tradeName>Astrovirus Ag Test Device-Feces</tradeName>
    <deviceName>Astrovirus Ag Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</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>D-FIASTD25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:16.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-FIASTD10TW</udiDi>
    <basicUdiDi>B-D-FIASTD10TW</basicUdiDi>
    <tradeName>Astrovirus Ag Test Device-Feces</tradeName>
    <deviceName>Astrovirus Ag Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</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>D-FIASTD10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:15.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Crypto-F238W</udiDi>
    <basicUdiDi>B-Crypto-F238W</basicUdiDi>
    <tradeName>D-Crypto-F238W</tradeName>
    <deviceName>Cryptosporidium 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Crypto-F23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:32.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062710721</udiDi>
    <basicUdiDi>69520627J017LD</basicUdiDi>
    <tradeName>Influenza A+B &amp; COVID-19 (SARS-CoV-2)  Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVAg+FluAB1NST-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062710745</udiDi>
    <basicUdiDi>69520627J017LD</basicUdiDi>
    <tradeName>Influenza A+B &amp; COVID-19 (SARS-CoV-2)  Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVAg+FluAB1NST-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062710752</udiDi>
    <basicUdiDi>69520627J017LD</basicUdiDi>
    <tradeName>Influenza A+B &amp; COVID-19 (SARS-CoV-2)  Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVAg+FluAB1NST-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062710769</udiDi>
    <basicUdiDi>69520627J017LD</basicUdiDi>
    <tradeName>Influenza A+B &amp; COVID-19 (SARS-CoV-2)  Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVAg+FluAB1NST-10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062710776</udiDi>
    <basicUdiDi>69520627J017LD</basicUdiDi>
    <tradeName>Influenza A+B &amp; COVID-19 (SARS-CoV-2)  Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVAg+FluAB1NST-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062710783</udiDi>
    <basicUdiDi>69520627J017LD</basicUdiDi>
    <tradeName>Influenza A+B &amp; COVID-19 (SARS-CoV-2)  Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVAg+FluAB1NST-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062711650</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg1FEST-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062711667</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg1FEST-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062711674</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg1FEST-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062711681</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg1FEST-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062711698</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg4FEST-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062711704</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg4FEST-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062711711</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg4FEST-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774037</udiDi>
    <basicUdiDi>69520627J034LD</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A+B &amp; RSV &amp; ADV Antigen Combo Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFRA1ST-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774044</udiDi>
    <basicUdiDi>69520627J034LD</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A+B &amp; RSV &amp; ADV Antigen Combo Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFRA1ST-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.666Z</lastUpdated>
  </row>
</eudamedExport>