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<eudamedExport entity="devices">
  <row>
    <udiDi>04065384000172</udiDi>
    <basicUdiDi>4065384STA1OPS4N1GXEW</basicUdiDi>
    <tradeName>NADAL® Strep A Test</tradeName>
    <deviceName>Strep A Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20122N20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:21:47.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972412612031</udiDi>
    <basicUdiDi>0697241261IRS-RA5229P</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Respiratory multiple 2 in 1 test kit (RSV/Adeno)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303045201-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:52:15.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972412611478</udiDi>
    <basicUdiDi>0697241261IRS-572BQ</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Respiratory multiple 7 in 1 test kit  (FluA/FluB/COVID-19/RSV/Adeno/MP/HMPV)</deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303041901-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:52:14.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITGC-535J7</udiDi>
    <basicUdiDi>B-ITGC-535J7</basicUdiDi>
    <tradeName>Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test</tradeName>
    <deviceName>Trichomonas vaginalis/Gardnerella vaginalis/ Candida albicans Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITGC-535</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:09:30.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISB-502SC</udiDi>
    <basicUdiDi>B-ISB-502SC</basicUdiDi>
    <tradeName>Strep B Rapid Test Cassette</tradeName>
    <deviceName>Strep B Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISB-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:09:26.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISB-501SA</udiDi>
    <basicUdiDi>B-ISB-501SA</basicUdiDi>
    <tradeName>Strep B Rapid Test Dipstick</tradeName>
    <deviceName>Strep B Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISB-501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:09:24.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>20608337000560</udiDi>
    <basicUdiDi>B-20608337000560</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, 25 Count</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0270</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:06:15.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVCAB-ACO627BC</udiDi>
    <basicUdiDi>B-IVCAB-ACO627BC</basicUdiDi>
    <tradeName>Vibrio cholerae O1/O139 Combo Rapid Test</tradeName>
    <deviceName>Vibrio cholerae O1/O139 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVCAB-ACO627</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:49:16.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITYM-ACO402S9</udiDi>
    <basicUdiDi>B-ITYM-ACO402S9</basicUdiDi>
    <tradeName>Typhoid IgM Rapid Test Cassette</tradeName>
    <deviceName>Typhoid IgM 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>ITYM-ACO402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:59.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITYG-ACO402NP</udiDi>
    <basicUdiDi>B-ITYG-ACO402NP</basicUdiDi>
    <tradeName>Typhoid IgG Rapid Test Cassette</tradeName>
    <deviceName>Typhoid IgG 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>ITYG-ACO402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:59.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISTY-ACO607VH</udiDi>
    <basicUdiDi>B-ISTY-ACO607VH</basicUdiDi>
    <tradeName>Salmonella Typhi Antigen Rapid Test</tradeName>
    <deviceName>Salmonella Typhi Antigen 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTY-ACO607</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:58.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISTPB-ACO6272Q</udiDi>
    <basicUdiDi>B-ISTPB-ACO6272Q</basicUdiDi>
    <tradeName>Salmonella typhi and paratyphi B Antigen Combo Rapid Test</tradeName>
    <deviceName>Salmonella typhi and paratyphi 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTPB-ACO627</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:57.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISTPB-ACO6252L</udiDi>
    <basicUdiDi>B-ISTPB-ACO6252L</basicUdiDi>
    <tradeName>Salmonella typhi and paratyphi B Antigen Combo Rapid Test</tradeName>
    <deviceName>Salmonella typhi and paratyphi 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTPB-ACO625</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:53.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISTP-ACO627QC</udiDi>
    <basicUdiDi>B-ISTP-ACO627QC</basicUdiDi>
    <tradeName>Salmonella typhi and paratyphi Antigen Combo Rapid Test</tradeName>
    <deviceName>Salmonella typhi and paratyphi 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTP-ACO627</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:52.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IST-502(CT)Q4</udiDi>
    <basicUdiDi>B-IST-502(CT)Q4</basicUdiDi>
    <tradeName>D-IST-502(CT)Q4</tradeName>
    <deviceName>Strep A Rapid Test Cassette</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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-502(CT)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:51.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISPT-ACO607PN</udiDi>
    <basicUdiDi>B-ISPT-ACO607PN</basicUdiDi>
    <tradeName>Salmonella paratyphi Antigen Rapid Test</tradeName>
    <deviceName>Salmonella paratyphi Antigen 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISPT-ACO607</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:50.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISHS-ACO607HB</udiDi>
    <basicUdiDi>B-ISHS-ACO607HB</basicUdiDi>
    <tradeName>Shigella Sonnei Antigen Rapid Test</tradeName>
    <deviceName>Shigella Sonnei Antigen 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISHS-ACO607</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:47.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISHS-ACO602GZ</udiDi>
    <basicUdiDi>B-ISHS-ACO602GZ</basicUdiDi>
    <tradeName>Shigella Sonnei Antigen Rapid Test Cassette</tradeName>
    <deviceName>Shigella Sonnei Antigen 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>ISHS-ACO602</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:46.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISHF-ACO6079L</udiDi>
    <basicUdiDi>B-ISHF-ACO6079L</basicUdiDi>
    <tradeName>Shigella Flexneri Antigen Rapid Test</tradeName>
    <deviceName>Shigella Flexneri Antigen 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISHF-ACO607</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:45.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISHF-ACO6029A</udiDi>
    <basicUdiDi>B-ISHF-ACO6029A</basicUdiDi>
    <tradeName>Shigella Flexneri Antigen Rapid Test Cassette</tradeName>
    <deviceName>Shigella Flexneri Antigen 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>ISHF-ACO602</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:44.522Z</lastUpdated>
  </row>
</eudamedExport>