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    <deviceName>Four Bacteria Combined Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:14.607Z</lastUpdated>
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    <udiDi>06975578360198</udiDi>
    <basicUdiDi>B-06975578360198</basicUdiDi>
    <tradeName>06975578360198</tradeName>
    <deviceName>Five Streptococcus Species Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <udiDi>06975578360181</udiDi>
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    <deviceName>Bloodstream Infection Pathogen and Antimicrobial Resistance Gene Nucleic Acid Detection Kit　(Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
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    <deviceName>Six Candida Species Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</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>2000261</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:09.782Z</lastUpdated>
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    <udiDi>06975578360150</udiDi>
    <basicUdiDi>B-06975578360150</basicUdiDi>
    <tradeName>06975578360150</tradeName>
    <deviceName>Invasive Fungal Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000244</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:08.186Z</lastUpdated>
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    <udiDi>06975578360143</udiDi>
    <basicUdiDi>B-06975578360143</basicUdiDi>
    <tradeName>06975578360143</tradeName>
    <deviceName>Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detection Kit (Digital PCR Method）</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000236</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:05.797Z</lastUpdated>
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    <tradeName>06975578360129</tradeName>
    <deviceName>PilotTM Encephalitis /Meningitis Digital PCR Kit</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000266</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:04.182Z</lastUpdated>
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    <udiDi>08435440242239</udiDi>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:12.600Z</lastUpdated>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HNS113L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:11.746Z</lastUpdated>
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    <udiDi>08435440207962</udiDi>
    <basicUdiDi>84354402_MDXMENIN_HNSZ7</basicUdiDi>
    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T19:53:11.267Z</lastUpdated>
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    <udiDi>08435440216469</udiDi>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HNS196T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:08.821Z</lastUpdated>
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    <udiDi>08435440242246</udiDi>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HNS101</reference>
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    <lastUpdated>2026-07-06T19:52:56.856Z</lastUpdated>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <lastUpdated>2026-07-06T19:52:23.862Z</lastUpdated>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T19:51:40.982Z</lastUpdated>
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