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<eudamedExport entity="devices">
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    <udiDi>08436040329436</udiDi>
    <basicUdiDi>843604032RTPCR01601W4</basicUdiDi>
    <tradeName>MYCOBACTERIUM REALTIME PCR KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR016-LPD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:29.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792743700</udiDi>
    <basicUdiDi>69557927S3354E000001TQ</basicUdiDi>
    <tradeName>06955792743700</tradeName>
    <deviceName>Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3354E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:27:58.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145191377</udiDi>
    <basicUdiDi>4987026TD-LFTBZE</basicUdiDi>
    <tradeName>Loopamp™ MTBC Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>972000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:30:57.899Z</lastUpdated>
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  <row>
    <udiDi>D-G2M707421FY</udiDi>
    <basicUdiDi>B-G2M707421FY</basicUdiDi>
    <tradeName>MTB-NTM Multiplex Real-Time PCR Kit</tradeName>
    <deviceName>MTB-NTM Multiplex Real-Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M707421,G2M707421R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:37.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CMTBRIF01A4ULZ</udiDi>
    <basicUdiDi>B-697603130CMTBRIF01A4ULZ</basicUdiDi>
    <tradeName>D-697603130CMTBRIF01A4ULZ</tradeName>
    <deviceName>GeneStream MTB/RIF 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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBRIF01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:15.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CMTB01AHG46</udiDi>
    <basicUdiDi>B-697603130CMTB01AHG46</basicUdiDi>
    <tradeName>D-697603130CMTB01AHG46</tradeName>
    <deviceName>GeneStream MTB 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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTB01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:10.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130A0205EYRX57</udiDi>
    <basicUdiDi>B-697603130A0205EYRX57</basicUdiDi>
    <tradeName>D-697603130A0205EYRX57</tradeName>
    <deviceName>Mycobacterium Tuberculosis Complex 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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0205EY，101A0205ED</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:42.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960RMTB01ZMGA</udiDi>
    <basicUdiDi>B-69509960RMTB01ZMGA</basicUdiDi>
    <tradeName>D-69509960RMTB01ZMGA</tradeName>
    <deviceName>Rapid MTBC DNA Test</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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RMTB01-AHG5E, RMTB01-AHG25E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:53:06.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AMTBC01WULG</udiDi>
    <basicUdiDi>B-69509960AMTBC01WULG</basicUdiDi>
    <tradeName>D-69509960AMTBC01WULG</tradeName>
    <deviceName>Mycobacterium Tuberculosis Complex 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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:56.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007515</udiDi>
    <basicUdiDi>B-07332940007515</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® MTB/XDR</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXMTB/XDR-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:10.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940002138</udiDi>
    <basicUdiDi>B-07332940002138</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® MTB/RIF Ultra</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXMTB/RIF-ULTRA-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:44.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940002121</udiDi>
    <basicUdiDi>B-07332940002121</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® MTB/RIF Ultra</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXMTB/RIF-ULTRA-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:43.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBXDRRTS7</udiDi>
    <basicUdiDi>B-TRMF000028405MTBXDRRTS7</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB/XDR Detection Kit, 25T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB/XDR-RT25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:53.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBRT100HC</udiDi>
    <basicUdiDi>B-TRMF000028405MTBRT100HC</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB Detection Kit, 100T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB-RT100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:51.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBNRT10LX</udiDi>
    <basicUdiDi>B-TRMF000028405MTBNRT10LX</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB/NTM Detection Kit, 100T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTBN-RT100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:49.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBMDRRTNE</udiDi>
    <basicUdiDi>B-TRMF000028405MTBMDRRTNE</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB/MDR Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB/MDR-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:48.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNVC-CED-06XC</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-06XC</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-06XC</tradeName>
    <deviceName>Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Henan Vacure Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023292</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:01.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB02KD</udiDi>
    <basicUdiDi>B-TB02KD</basicUdiDi>
    <tradeName>Cowingene MTB and NTM Detection Kit</tradeName>
    <deviceName>Cowingene MTB and NTM Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB02021X, TB02022X, TB02023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:01.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB01KB</udiDi>
    <basicUdiDi>B-TB01KB</basicUdiDi>
    <tradeName>Cowingene Mycobacterium Tuberculosis Detection Kit</tradeName>
    <deviceName>Cowingene Mycobacterium Tuberculosis Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB01021X, TB01022X, TB01023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:01.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTB-K-0074D</udiDi>
    <basicUdiDi>B-MTB-K-0074D</basicUdiDi>
    <tradeName>Logix Smart MTB Test Kit</tradeName>
    <deviceName>Logix Smart MTB Test Kit</deviceName>
    <manufacturerName>Co-Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036425</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB-K-007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:12.330Z</lastUpdated>
  </row>
</eudamedExport>