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    <tradeName>GeneMind</tradeName>
    <deviceName>Hereditary Deafness Gene Detection Kit (Sequencing Method)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
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    <tradeName>GeneMind</tradeName>
    <deviceName>Cystic Fibrosis Detection Kit (Sequencing Method)</deviceName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <tradeName>GeneMind</tradeName>
    <deviceName>Drug Resistance Detection Kit in Tuberculosis (Sequencing Method)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
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    <tradeName>Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit ( Reversible Terminator Sequencing)</tradeName>
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    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
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    <tradeName>Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <tradeName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>BRCA 1+2</emdnDescription>
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    <deviceName>Nipah Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceName>Nipah Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <deviceName>Coxsackievirus A6/A10/A16 &amp; Enterovirus 71 &amp; Enterovirus Universal Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:34.758Z</lastUpdated>
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    <deviceName>Coxsackievirus A6/A10/A16 &amp; Enterovirus 71 &amp; Enterovirus Universal Nucleic Acid Test Kit (PCR-Fluorescent Probe  Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <deviceName>Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:29.147Z</lastUpdated>
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    <deviceName>Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <deviceName>Dermatophyte Nucleic Acid 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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    <deviceName>Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR  Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <deviceName>Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <deviceName>Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <deviceName>Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
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    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <deviceName>Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent  PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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