<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ISIC-ACOR525JU</udiDi>
    <basicUdiDi>B-ISIC-ACOR525JU</basicUdiDi>
    <tradeName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISIC-ACOR525</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:57.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMVD-645M6</udiDi>
    <basicUdiDi>B-IMVD-645M6</basicUdiDi>
    <tradeName>D-IMVD-645M6</tradeName>
    <deviceName>Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>CITEST DIAGNOSTICS INC</manufacturerName>
    <manufacturerSrn>CA-MF-000022516</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>IMVD-645</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:56.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-R402(ACRO)36</udiDi>
    <basicUdiDi>B-IHP-R402(ACRO)36</basicUdiDi>
    <tradeName>H. pylori Antibody Rapid Test Cassette</tradeName>
    <deviceName>H. pylori Antibody Rapid Test Cassette</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-R402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:52.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHP-602(CT)BS</udiDi>
    <basicUdiDi>B-IHP-602(CT)BS</basicUdiDi>
    <tradeName>D-IHP-602(CT)BS</tradeName>
    <deviceName>H.pylori Antigen Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>CITEST DIAGNOSTICS INC</manufacturerName>
    <manufacturerSrn>CA-MF-000022516</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-602(CT)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:51.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICD-635B(CT)XM</udiDi>
    <basicUdiDi>B-ICD-635B(CT)XM</basicUdiDi>
    <tradeName>D-ICD-635B(CT)XM</tradeName>
    <deviceName>Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>CITEST DIAGNOSTICS INC</manufacturerName>
    <manufacturerSrn>CA-MF-000022516</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICD-635B(CT)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:51.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICAM-6029U</udiDi>
    <basicUdiDi>B-ICAM-6029U</basicUdiDi>
    <tradeName>D-ICAM-6029U</tradeName>
    <deviceName>Campylobacter Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>CITEST DIAGNOSTICS INC</manufacturerName>
    <manufacturerSrn>CA-MF-000022516</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICAM-602</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:50.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FLH-103H(ACRO)7Y</udiDi>
    <basicUdiDi>B-FLH-103H(ACRO)7Y</basicUdiDi>
    <tradeName>LH Ovulation Rapid Test Midstream</tradeName>
    <deviceName>LH Ovulation Rapid Test Midstream</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-103H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:46.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIG-501(ACRO)WA</udiDi>
    <basicUdiDi>B-FIG-501(ACRO)WA</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test Dipstick</tradeName>
    <deviceName>iGFBP-1 Rapid Test Dipstick</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:45.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U103H(ACRO)QV</udiDi>
    <basicUdiDi>B-FHC-U103H(ACRO)QV</basicUdiDi>
    <tradeName>hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream</tradeName>
    <deviceName>hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U103H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:44.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-103H(ACRO)UY</udiDi>
    <basicUdiDi>B-FHC-103H(ACRO)UY</basicUdiDi>
    <tradeName>hCG Pregnancy Rapid Test Midstream</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Midstream</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-103H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:43.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DSC-ACOR102ZE</udiDi>
    <basicUdiDi>B-DSC-ACOR102ZE</basicUdiDi>
    <tradeName>SCOP Rapid Test Cassette</tradeName>
    <deviceName>SCOP Rapid Test Cassette</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSC-ACOR102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:39.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCOD-ACO114R5</udiDi>
    <basicUdiDi>B-DCOD-ACO114R5</basicUdiDi>
    <tradeName>Codeine (COD) Rapid Test</tradeName>
    <deviceName>Codeine (COD) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCOD-ACO114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:39.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCOD-ACO111QX</udiDi>
    <basicUdiDi>B-DCOD-ACO111QX</basicUdiDi>
    <tradeName>Codeine (COD) Rapid Test</tradeName>
    <deviceName>Codeine (COD) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCOD-ACO111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:38.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCOD-ACO102QW</udiDi>
    <basicUdiDi>B-DCOD-ACO102QW</basicUdiDi>
    <tradeName>Codeine (COD) Rapid Test</tradeName>
    <deviceName>Codeine (COD) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCOD-ACO102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:37.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCOD-ACO101QU</udiDi>
    <basicUdiDi>B-DCOD-ACO101QU</basicUdiDi>
    <tradeName>Codeine (COD) Rapid Test</tradeName>
    <deviceName>Codeine (COD) Rapid Test</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCOD-ACO101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:52:32.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971824209068</udiDi>
    <basicUdiDi>B-06971824209068</basicUdiDi>
    <tradeName>Wondfo Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F141C</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:55.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971824208986</udiDi>
    <basicUdiDi>B-06971824208986</basicUdiDi>
    <tradeName>Wondfo Alpha-fetoprotein (CLIA)</tradeName>
    <deviceName>Alpha-fetoprotein (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F76C</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:55.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971824209051</udiDi>
    <basicUdiDi>B-06971824209051</basicUdiDi>
    <tradeName>Wondfo Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F141A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:55.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971824208979</udiDi>
    <basicUdiDi>B-06971824208979</basicUdiDi>
    <tradeName>Wondfo Alpha-fetoprotein (CLIA)</tradeName>
    <deviceName>Alpha-fetoprotein (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F76A</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:55.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971824208962</udiDi>
    <basicUdiDi>B-06971824208962</basicUdiDi>
    <tradeName>Wondfo Alpha-fetoprotein (CLIA)</tradeName>
    <deviceName>Alpha-fetoprotein (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F60C</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:50.628Z</lastUpdated>
  </row>
</eudamedExport>