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    <deviceName>Six Carbapenem-resistant Gene 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>ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <deviceName>ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <deviceName>Six Carbapenem-resistant Gene Nucleic Acid Test Kit   (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06974795550313</basicUdiDi>
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    <deviceName>Five Invasive Fungal 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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210111B</reference>
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    <tradeName>06974795550306</tradeName>
    <deviceName>Five Invasive Fungal 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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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06974795550290</basicUdiDi>
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    <deviceName>Five Candida 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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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Five Candida 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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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:43:38.468Z</lastUpdated>
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    <udiDi>06974689626650</udiDi>
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    <tradeName>Blood pathogens and drug resistance genes real-time PCR detection kit</tradeName>
    <deviceName>Blood pathogens and drug resistance genes real-time PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13900</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:21.750Z</lastUpdated>
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    <udiDi>06974689626643</udiDi>
    <basicUdiDi>B-06974689626643</basicUdiDi>
    <tradeName>Pathogens nucleic acid digital PCR detection kit</tradeName>
    <deviceName>Pathogens nucleic acid digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13874</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:20.947Z</lastUpdated>
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    <udiDi>06974689626636</udiDi>
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    <tradeName>Blood pathogens and drug resistance genes digital PCR detection kit</tradeName>
    <deviceName>Blood pathogens and drug resistance genes digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13696</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:20.148Z</lastUpdated>
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    <udiDi>06974674892473</udiDi>
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    <tradeName>Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) 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>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:13.413Z</lastUpdated>
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    <tradeName>06974323011576</tradeName>
    <deviceName>Triplex Real-Time PCR Kit for Detection of Aspergillus, Cryptococcus neoformans and Pneumocystis</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>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT8143</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:52.624Z</lastUpdated>
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    <tradeName>06974323010111</tradeName>
    <deviceName>Triplex Real-Time PCR Kit for Detection of Aspergillus, Cryptococcus neoformans and Pneumocystis</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT8143</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:07.818Z</lastUpdated>
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    <tradeName>iSolutions™ Essential Enteric Bacteria Fullplex qPCR</tradeName>
    <deviceName>IS-ENTBAC-100 (FR) - Boîtes</deviceName>
    <manufacturerName>ID SOLUTIONS</manufacturerName>
    <manufacturerSrn>FR-MF-000024876</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:19.792Z</lastUpdated>
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    <tradeName>iSolutions™ Enteric Bacteria &amp; C. difficile Fullplex qPCR</tradeName>
    <deviceName>IS-ENTBAC-CD-100 (FR) - Boîtes</deviceName>
    <manufacturerName>ID SOLUTIONS</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:18.189Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
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    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1300</reference>
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    <lastUpdated>2026-07-03T21:03:47.587Z</lastUpdated>
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    <tradeName>QIAstat-Dx BCID GPF Plus AMR Panel</tradeName>
    <deviceName>QIAstat-Dx BCID GPF Plus AMR Panel</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>691812</reference>
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    <lastUpdated>2026-07-01T16:24:02.135Z</lastUpdated>
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    <tradeName>Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)</tradeName>
    <deviceName>Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3310E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:40.550Z</lastUpdated>
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    <deviceName>Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3310E-12-S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:27:20.054Z</lastUpdated>
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