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<eudamedExport entity="devices">
  <row>
    <udiDi>D-697994388Fa002W55Y</udiDi>
    <basicUdiDi>B-697994388Fa002W55Y</basicUdiDi>
    <tradeName>D-697994388Fa002W55Y</tradeName>
    <deviceName>Yellow Fever Virus Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:19:02.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CRTIZK018VDM</udiDi>
    <basicUdiDi>B-697603130CRTIZK018VDM</basicUdiDi>
    <tradeName>D-697603130CRTIZK018VDM</tradeName>
    <deviceName>GeneStream RTI Controls</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRTIZK01-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:23.211Z</lastUpdated>
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  <row>
    <udiDi>D-697603130CMTBMDR01A3QKW</udiDi>
    <basicUdiDi>B-697603130CMTBMDR01A3QKW</basicUdiDi>
    <tradeName>D-697603130CMTBMDR01A3QKW</tradeName>
    <deviceName>GeneStream MTB MDR Assay</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBMDR01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:10.429Z</lastUpdated>
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  <row>
    <udiDi>D-697603130CDGV01ADQY7</udiDi>
    <basicUdiDi>B-697603130CDGV01ADQY7</basicUdiDi>
    <tradeName>D-697603130CDGV01ADQY7</tradeName>
    <deviceName>GeneStream Dengue Virus Typing Assay</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDGV01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:00.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130AMPV01EMWG</udiDi>
    <basicUdiDi>B-697603130AMPV01EMWG</basicUdiDi>
    <tradeName>D-697603130AMPV01EMWG</tradeName>
    <deviceName>Monkeypox Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPV01，AMPV01D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:55.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130AFCRC01CZYA</udiDi>
    <basicUdiDi>B-697603130AFCRC01CZYA</basicUdiDi>
    <tradeName>D-697603130AFCRC01CZYA</tradeName>
    <deviceName>Flu A/Flu B/CoV-2/RSV Controls</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFCRC01-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:51.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130A0211EYRJ3C</udiDi>
    <basicUdiDi>B-697603130A0211EYRJ3C</basicUdiDi>
    <tradeName>D-697603130A0211EYRJ3C</tradeName>
    <deviceName>Dengue Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0211EY，101A0211ED</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:45.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120084296</udiDi>
    <basicUdiDi>B-697177120084296</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Influenza A/B Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU-S21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:03.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AMPV01UYBQ</udiDi>
    <basicUdiDi>B-69509960AMPV01UYBQ</basicUdiDi>
    <tradeName>D-69509960AMPV01UYBQ</tradeName>
    <deviceName>Monkeypox Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPV01-AOG48E; AMPV01-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:56.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960ADV01QJRZ</udiDi>
    <basicUdiDi>B-69509960ADV01QJRZ</basicUdiDi>
    <tradeName>D-69509960ADV01QJRZ</tradeName>
    <deviceName>Dengue Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV01-AOG48E;,ADV01-AOG96E,ADV01D-AOG48E,ADV01D-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:17.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5713915CD002LC9H</udiDi>
    <basicUdiDi>B-5713915CD002LC9H</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetec FAST COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8016; 8018; 8022</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:30.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5713915CD001LA98</udiDi>
    <basicUdiDi>B-5713915CD001LA98</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetect COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8015, 8010, 8079</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:29.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>5713915CD003LE9S</udiDi>
    <basicUdiDi>B-5713915CD003LE9S</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetect™ ULTRA COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8213, 8214</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:40:59.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989408</udiDi>
    <basicUdiDi>B-08908007989408</basicUdiDi>
    <tradeName>Truenat H1N1</tradeName>
    <deviceName>Truenat H1N1</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601070050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:10:31.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595033838</udiDi>
    <basicUdiDi>B-08684595033838</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>MPXV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP71P50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:15:03.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032107</udiDi>
    <basicUdiDi>B-08684595032107</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>MPXV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP71P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:15:02.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940000981</udiDi>
    <basicUdiDi>B-07332940000981</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Norovirus</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040516</emdnCode>
    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXNOV-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:10.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIPRSV61640_</udiDi>
    <basicUdiDi>B-+ENTIPRSV61640_</basicUdiDi>
    <tradeName>+ENTIPRSV61640_</tradeName>
    <deviceName>RSV A, RSV B</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRSV6164</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:45.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIPRSV61610Z</udiDi>
    <basicUdiDi>B-+ENTIPRSV61610Z</basicUdiDi>
    <tradeName>+ENTIPRSV61610Z</tradeName>
    <deviceName>RSV A, RSV B</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRSV6161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:44.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIPRES61340I</udiDi>
    <basicUdiDi>B-+ENTIPRES61340I</basicUdiDi>
    <tradeName>+ENTIPRES61340I</tradeName>
    <deviceName>Mplex SARS-CoV-2+, Flu A, Flu B (C1)</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRES6134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:43.234Z</lastUpdated>
  </row>
</eudamedExport>