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    <tradeName>NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>NTM 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>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105010703</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T16:59:04.140Z</lastUpdated>
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    <basicUdiDi>B-06974566304060</basicUdiDi>
    <tradeName>NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>NTM Identification and Differentiation 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>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>06974566304053</udiDi>
    <basicUdiDi>B-06974566304053</basicUdiDi>
    <tradeName>NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis)</tradeName>
    <deviceName>NTM Identification and Differentiation 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>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Greece</placedOnMarketCountry>
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    <udiDi>06974566304046</udiDi>
    <basicUdiDi>B-06974566304046</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>PMTB0548</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:58.533Z</lastUpdated>
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    <udiDi>06974566304022</udiDi>
    <basicUdiDi>B-06974566304022</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>PMTB0524</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:57.736Z</lastUpdated>
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    <udiDi>06974566304015</udiDi>
    <basicUdiDi>B-06974566304015</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>PMTB0348</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:56.932Z</lastUpdated>
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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>
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    <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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    <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>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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    <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>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>
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    <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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    <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>
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    <riskClass>IVD Genel</riskClass>
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    <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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    <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>
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    <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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    <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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    <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>
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    <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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    <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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    <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>
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    <riskClass>IVD Genel</riskClass>
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    <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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    <basicUdiDi>B-06972221450541</basicUdiDi>
    <tradeName>06972221450541</tradeName>
    <deviceName>Mycobacteria Real-time PCR Detection Kit</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests /kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:20.680Z</lastUpdated>
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