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    <manufacturerName>Cepheid</manufacturerName>
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    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:52.163Z</lastUpdated>
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    <manufacturerName>Cepheid AB</manufacturerName>
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    <tradeName>Xpert®</tradeName>
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    <manufacturerName>Cepheid AB</manufacturerName>
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    <tradeName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA1FE-20</reference>
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    <lastUpdated>2026-07-16T15:55:57.039Z</lastUpdated>
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    <tradeName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
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    <deviceName>STANDARD™ M10 Flu/RSV/SARS-CoV-2 Fast</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11FLU30A</reference>
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    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HNS106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <tradeName>Panther Fusion GI Expanded Bacterial Assay</tradeName>
    <deviceName>Panther Fusion GI Expanded Bacterial Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07121</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:02:47.383Z</lastUpdated>
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    <tradeName>Panther Fusion GI Bacterial Assay</tradeName>
    <deviceName>Panther Fusion GI Bacterial Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07113</reference>
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    <lastUpdated>2026-07-16T07:02:45.782Z</lastUpdated>
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    <tradeName>res4plex direct RT-PCR</tradeName>
    <deviceName>res4plex direct RT-PCR</deviceName>
    <manufacturerName>FRIZ Biochem GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017533</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBC107-Cx</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:20:59.102Z</lastUpdated>
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    <tradeName>QIAstat-Dx Gastrointestinal Panel 2</tradeName>
    <deviceName>QIAstat-Dx Gastrointestinal Panel 2</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>691413</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:31:44.970Z</lastUpdated>
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    <tradeName>Alinity m</tradeName>
    <deviceName>Alinity m Resp-4-Plex</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N79-092</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:24:11.435Z</lastUpdated>
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    <tradeName>Alinity m</tradeName>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
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    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N79-090</reference>
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    <lastUpdated>2026-07-16T04:23:52.224Z</lastUpdated>
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    <tradeName>Alinity m</tradeName>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
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    <reference>09N17-091</reference>
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    <tradeName>Alinity m</tradeName>
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    <tradeName>cobas® eplex respiratory pathogen panel 3 (RP3)</tradeName>
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    <manufacturerName>GenMark Diagnostics</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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