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    <tradeName>Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Mycobacterium tuberculosis</tradeName>
    <deviceName>Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Mycobacterium tuberculosis</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <deviceName>Mycobacteriaceae Identification Test Kit  (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <deviceName>Mycobacteriaceae Identification Test Kit  (PCR-Fluorescent Probe Method)</deviceName>
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    <deviceName>Mycobacterium Tuberculosis Isoniazid and Fluoroquinolone Resistance Gene Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <basicUdiDi>B-06974795550245</basicUdiDi>
    <tradeName>06974795550245</tradeName>
    <deviceName>Mycobacterium Tuberculosis Isoniazid and Fluoroquinolone Resistance Gene Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06974795550238</basicUdiDi>
    <tradeName>06974795550238</tradeName>
    <deviceName>Mycobacterium Tuberculosis and Rifampicin Resistance Gene Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210001A</reference>
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    <tradeName>06974795550221</tradeName>
    <deviceName>Mycobacterium Tuberculosis and Rifampicin Resistance Gene Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE MTB Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018013905-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:28.769Z</lastUpdated>
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    <basicUdiDi>B-06974767393054</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE MTB Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</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>6018013902-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:24.763Z</lastUpdated>
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    <udiDi>06974674892503</udiDi>
    <basicUdiDi>B-06974674892503</basicUdiDi>
    <tradeName>Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:19.012Z</lastUpdated>
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    <basicUdiDi>B-06974566304091</basicUdiDi>
    <tradeName>NTM Drugs Susceptibility Test Kit</tradeName>
    <deviceName>NTM Drugs Susceptibility Test Kit</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>PNTM010</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:59:08.939Z</lastUpdated>
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    <basicUdiDi>B-06974566304084</basicUdiDi>
    <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>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM0424</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:59:04.940Z</lastUpdated>
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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>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM0448</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
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    <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>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNTM024</reference>
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    <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>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0548</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
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    <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>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <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>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <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>
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    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0248</reference>
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    <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>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMTB0224</reference>
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    <lastUpdated>2026-07-06T16:58:51.334Z</lastUpdated>
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