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<eudamedExport entity="devices">
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    <udiDi>06974566304008</udiDi>
    <basicUdiDi>B-06974566304008</basicUdiDi>
    <tradeName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0248</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:56.127Z</lastUpdated>
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  <row>
    <udiDi>06974566303995</udiDi>
    <basicUdiDi>B-06974566303995</basicUdiDi>
    <tradeName>(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0224</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:51.334Z</lastUpdated>
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    <udiDi>06974566302820</udiDi>
    <basicUdiDi>B-06974566302820</basicUdiDi>
    <tradeName>Tuberculosis Antibody Rapid Test</tradeName>
    <deviceName>Tuberculosis Antibody Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</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>ITA-812</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:23.264Z</lastUpdated>
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    <udiDi>06974323013518</udiDi>
    <basicUdiDi>B-06974323013518</basicUdiDi>
    <tradeName>06974323013518</tradeName>
    <deviceName>"Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Test Cassette  (Rare earth nanorare earth nano fluorescence immunochromatography)"</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:54:10.768Z</lastUpdated>
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  <row>
    <udiDi>06974323013501</udiDi>
    <basicUdiDi>B-06974323013501</basicUdiDi>
    <tradeName>06974323013501</tradeName>
    <deviceName>"Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Test Cassette  (Rare earth nanorare earth nano fluorescence immunochromatography)"</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:54:09.966Z</lastUpdated>
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  <row>
    <udiDi>06974323012948</udiDi>
    <basicUdiDi>B-06974323012948</basicUdiDi>
    <tradeName>06974323012948</tradeName>
    <deviceName>PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:14.580Z</lastUpdated>
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  <row>
    <udiDi>06974323012931</udiDi>
    <basicUdiDi>B-06974323012931</basicUdiDi>
    <tradeName>06974323012931</tradeName>
    <deviceName>PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:13.774Z</lastUpdated>
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    <udiDi>06974323011842</udiDi>
    <basicUdiDi>B-06974323011842</basicUdiDi>
    <tradeName>06974323011842</tradeName>
    <deviceName>Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010702</emdnCode>
    <emdnDescription>MYCOBACTERIAL ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:48:48.743Z</lastUpdated>
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  <row>
    <udiDi>06974323011835</udiDi>
    <basicUdiDi>B-06974323011835</basicUdiDi>
    <tradeName>06974323011835</tradeName>
    <deviceName>Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010702</emdnCode>
    <emdnDescription>MYCOBACTERIAL ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:48:32.662Z</lastUpdated>
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  <row>
    <udiDi>06974323011828</udiDi>
    <basicUdiDi>B-06974323011828</basicUdiDi>
    <tradeName>06974323011828</tradeName>
    <deviceName>Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010702</emdnCode>
    <emdnDescription>MYCOBACTERIAL ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:48:31.864Z</lastUpdated>
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  <row>
    <udiDi>06974238910629</udiDi>
    <basicUdiDi>B-06974238910629</basicUdiDi>
    <tradeName>Tuberculosis IgG/IgM Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</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>HTB068T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:15.796Z</lastUpdated>
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  <row>
    <udiDi>06974081870415</udiDi>
    <basicUdiDi>B-06974081870415</basicUdiDi>
    <tradeName>Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method)</tradeName>
    <deviceName>Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method)</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</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>TB002-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:51:06.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974081870361</udiDi>
    <basicUdiDi>B-06974081870361</basicUdiDi>
    <tradeName>Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</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>TB001-48</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:51:01.072Z</lastUpdated>
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  <row>
    <udiDi>06973685471103</udiDi>
    <basicUdiDi>B-06973685471103</basicUdiDi>
    <tradeName>ANDiS MTB RIF/INH Resistance Detection Kit</tradeName>
    <deviceName>ANDiS MTB RIF/INH Resistance Detection Kit</deviceName>
    <manufacturerName>3D Biomedicine Science &amp; Technology Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000020934</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000000000306</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:31:56.211Z</lastUpdated>
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    <udiDi>06973685471097</udiDi>
    <basicUdiDi>B-06973685471097</basicUdiDi>
    <tradeName>ANDiS MTB Detection Kit</tradeName>
    <deviceName>ANDiS MTB Detection Kit</deviceName>
    <manufacturerName>3D Biomedicine Science &amp; Technology Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000020934</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000000000305</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:31:54.394Z</lastUpdated>
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    <udiDi>06973315739245</udiDi>
    <basicUdiDi>B-06973315739245</basicUdiDi>
    <tradeName>Logilet MTB/RIF Panel</tradeName>
    <deviceName>Logilet MTB/RIF Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTB01M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:02:53.452Z</lastUpdated>
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    <udiDi>06972221451210</udiDi>
    <basicUdiDi>B-06972221451210</basicUdiDi>
    <tradeName>06972221451210</tradeName>
    <deviceName>Mycobacterium Tuberculosis Isoniazid Resistance Detection Kit</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</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>32 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:41.425Z</lastUpdated>
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    <udiDi>06972221451203</udiDi>
    <basicUdiDi>B-06972221451203</basicUdiDi>
    <tradeName>06972221451203</tradeName>
    <deviceName>Mycobacterium Tuberculosis Rifampicin Resistant Detection Kit</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</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>32 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:40.907Z</lastUpdated>
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    <udiDi>06972221450565</udiDi>
    <basicUdiDi>B-06972221450565</basicUdiDi>
    <tradeName>06972221450565</tradeName>
    <deviceName>M.tuberculosis Drug Resistance Detection Array Kit</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:23.625Z</lastUpdated>
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    <udiDi>06972221450558</udiDi>
    <basicUdiDi>B-06972221450558</basicUdiDi>
    <tradeName>06972221450558</tradeName>
    <deviceName>Mycobacteria Identification Array Kit</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:21.363Z</lastUpdated>
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</eudamedExport>