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<eudamedExport entity="devices">
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    <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>
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  <row>
    <udiDi>08806133045336</udiDi>
    <basicUdiDi>880613300610C4</basicUdiDi>
    <tradeName>AFIAS IGRA-TB</tradeName>
    <deviceName>AFIAS IGRA-TB</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-99</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:44:05.316Z</lastUpdated>
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  <row>
    <udiDi>00860011123408</udiDi>
    <basicUdiDi>08600111234TM240B2</basicUdiDi>
    <tradeName>MYCOPROSAFE</tradeName>
    <deviceName>MYCOPROSAFE</deviceName>
    <manufacturerName>SALUBRIS, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038921</manufacturerSrn>
    <authorisedRepresentativeName>DIAGNOTIS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038248</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM240</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:53:41.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816387021039</udiDi>
    <basicUdiDi>081638702MycoNF</basicUdiDi>
    <tradeName>MycoDDR™ Trident™ Mycobacterium Digestion and Decontamination Reagent Sets</tradeName>
    <deviceName>Mycobacterium Digestion and Decontamination Reagent Sets</deviceName>
    <manufacturerName>IMMY, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025165</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TBNN1010-2.5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:21:34.693Z</lastUpdated>
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  <row>
    <udiDi>30382902451595</udiDi>
    <basicUdiDi>038290WOGVLVPOQK</basicUdiDi>
    <tradeName>MGIT</tradeName>
    <deviceName>BD MGIT™ TBc Identification Test</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010701</emdnCode>
    <emdnDescription>MYCOBACTERIAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>245159</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:48:28.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>30382904438068</udiDi>
    <basicUdiDi>038290CDZXTPZWHH</basicUdiDi>
    <tradeName>MAX</tradeName>
    <deviceName>BD MAX™ STR</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443806</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:31:03.812Z</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>
  <row>
    <udiDi>D-KR-TB-IGRA-01050W7U</udiDi>
    <basicUdiDi>B-KR-TB-IGRA-01050W7U</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01050W</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:13.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TB-IGRA-01020C65</udiDi>
    <basicUdiDi>B-KR-TB-IGRA-01020C65</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01020C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:10.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB20123NW-50TPG</udiDi>
    <basicUdiDi>B-JB20123NW-50TPG</basicUdiDi>
    <tradeName>Mycobacterium Tuberculosis Real Time PCR Kit</tradeName>
    <deviceName>Mycobacterium Tuberculosis Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB20123NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:34.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB20123NW-25TPG</udiDi>
    <basicUdiDi>B-JB20123NW-25TPG</basicUdiDi>
    <tradeName>Mycobacterium Tuberculosis Real Time PCR Kit</tradeName>
    <deviceName>Mycobacterium Tuberculosis Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB20123NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:33.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCTB-402aHGNZ</udiDi>
    <basicUdiDi>B-GCTB-402aHGNZ</basicUdiDi>
    <tradeName>Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010702</emdnCode>
    <emdnDescription>MYCOBACTERIAL ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTB-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:33.095Z</lastUpdated>
  </row>
</eudamedExport>