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    <tradeName>Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</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>HWTS-RT105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:11.536Z</lastUpdated>
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    <udiDi>D-000012807042309NR</udiDi>
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    <tradeName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT105C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <udiDi>D-000012807042208NJ</udiDi>
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    <tradeName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT105A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:53.873Z</lastUpdated>
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    <udiDi>D-00001280704210BNX</udiDi>
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    <tradeName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT105B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:49.871Z</lastUpdated>
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    <udiDi>08906213930061</udiDi>
    <basicUdiDi>89080153043B268NV</basicUdiDi>
    <tradeName>TRUPCR® MTBC OneStep Nested Kit</tradeName>
    <deviceName>TRUPCR® MTBC OneStep Nested Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B269</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:02:59.434Z</lastUpdated>
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    <udiDi>08806133045299</udiDi>
    <basicUdiDi>880613300138BZ</basicUdiDi>
    <tradeName>ichroma™ IGRA-TB 25</tradeName>
    <deviceName>ichroma™ 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>CFPC-86-1</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:20.853Z</lastUpdated>
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    <udiDi>08800111722929</udiDi>
    <basicUdiDi>88001117IPCA01MA19XT</basicUdiDi>
    <tradeName>STANDARD™ M10 MTB-RIF/INH</tradeName>
    <deviceName>STANDARD™ M10 MTB-RIF/INH</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>M10-MTB-02/11MTB30A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:52.230Z</lastUpdated>
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    <udiDi>08698918035546</udiDi>
    <basicUdiDi>869891803040059A</basicUdiDi>
    <tradeName>TDC</tradeName>
    <deviceName>TDC (20 TEST) _%4</deviceName>
    <manufacturerName>RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000021258</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04005020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:55:03.934Z</lastUpdated>
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    <udiDi>08681677201437</udiDi>
    <basicUdiDi>86816772DKHK</basicUdiDi>
    <tradeName>DECOMICS</tradeName>
    <deviceName>DECONTAMINATION AND CONCENTRATION KITS</deviceName>
    <manufacturerName>Innovative Biotechnology Organization Trade Limited Company</manufacturerName>
    <manufacturerSrn>TR-MF-000037634</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEC010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:33:14.714Z</lastUpdated>
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    <udiDi>08806133048986</udiDi>
    <basicUdiDi>880613300138BZ</basicUdiDi>
    <tradeName>ichroma™ IGRA-TB for 8</tradeName>
    <deviceName></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>CFPC-86-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:56.518Z</lastUpdated>
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    <udiDi>04053228015963</udiDi>
    <basicUdiDi>4053228RTBQFT0000000001W8</basicUdiDi>
    <tradeName>QFT-Plus Reference Lab Pack</tradeName>
    <deviceName>QuantiFERON-TB Gold Plus (QFT-Plus)</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622822</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:22:57.934Z</lastUpdated>
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    <udiDi>04049095200069</udiDi>
    <basicUdiDi>4049095TN88020000UD</basicUdiDi>
    <tradeName>04049095200069</tradeName>
    <deviceName>RIDA®QUICK TB</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TN8802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:30.180Z</lastUpdated>
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    <udiDi>04049095200052</udiDi>
    <basicUdiDi>4049095TC88060000MU</basicUdiDi>
    <tradeName>04049095200052</tradeName>
    <deviceName>RIDASCREEN® TB</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC8806</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:28.921Z</lastUpdated>
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    <udiDi>04049055003938</udiDi>
    <basicUdiDi>40490550300001005TZ</basicUdiDi>
    <tradeName>FluoroType® MTBDR VER 2.0</tradeName>
    <deviceName>FluoroType® MTBDR VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:48:21.054Z</lastUpdated>
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    <udiDi>04049055002610</udiDi>
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    <tradeName>GenoType MTBDRplus VER 2.0</tradeName>
    <deviceName>GenoType MTBDRplus VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
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    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>304A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:25.756Z</lastUpdated>
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    <udiDi>03770032939094</udiDi>
    <basicUdiDi>3770032939DCC050S4</basicUdiDi>
    <tradeName>DECOCENT</tradeName>
    <deviceName>DECOCENT</deviceName>
    <manufacturerName>DIAGNOTIS SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000035861</manufacturerSrn>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCC050</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:10.490Z</lastUpdated>
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    <tradeName>DECOMICS</tradeName>
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    <manufacturerName>DIAGNOTIS SAS</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T13:14:08.885Z</lastUpdated>
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    <tradeName>MYCOPROSAFE</tradeName>
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    <lastUpdated>2026-07-01T13:14:08.083Z</lastUpdated>
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    <tradeName>MYCOPROSAFE</tradeName>
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    <manufacturerName>DIAGNOTIS SAS</manufacturerName>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPS230-SP1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:04.081Z</lastUpdated>
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    <tradeName>MYCOPROSAFE</tradeName>
    <deviceName>MYCOPROSAFE</deviceName>
    <manufacturerName>DIAGNOTIS SAS</manufacturerName>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:02.480Z</lastUpdated>
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