<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>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>
  <row>
    <udiDi>06952062774051</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-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774068</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-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774075</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-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774082</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-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774099</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-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CHKV-W23MC</udiDi>
    <basicUdiDi>B-CHKV-W23MC</basicUdiDi>
    <tradeName>D-CHKV-W23MC</tradeName>
    <deviceName>Chikungunya IgG/IgM Rapid 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHKV-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:05:42.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CHA-W23PR</udiDi>
    <basicUdiDi>B-CHA-W23PR</basicUdiDi>
    <tradeName>D-CHA-W23PR</tradeName>
    <deviceName>Chagas Antibody Rapid 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:05:20.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CER818VBCY</udiDi>
    <basicUdiDi>B-CER818VBCY</basicUdiDi>
    <tradeName>HPVix</tradeName>
    <deviceName>CER818VB</deviceName>
    <manufacturerName>Abcerion Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CER818VB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:02:05.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CER818RTDQ</udiDi>
    <basicUdiDi>B-CER818RTDQ</basicUdiDi>
    <tradeName>HPVix</tradeName>
    <deviceName>CER818RT</deviceName>
    <manufacturerName>Abcerion Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CER818RT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:02:04.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B384VS</udiDi>
    <basicUdiDi>B-ABT-IDT-B384VS</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Saliva/ Nasopharyngeal Swab)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:24.939Z</lastUpdated>
  </row>
</eudamedExport>