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    <tradeName>BIOSYNEX AMPLIQUICK Respiratory Triplex</tradeName>
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    <tradeName>BIOSYNEX AMPLIQUICK Respiratory Duplex</tradeName>
    <deviceName>BIOSYNEX AMPLIQUICK Respiratory duplex</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
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    <tradeName>BIOSYNEX AMPLIQUICK Respiratory Duplex</tradeName>
    <deviceName>BIOSYNEX AMPLIQUICK Respiratory duplex</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
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    <tradeName>PlexPCR Flu/RSV/SARS-CoV-2</tradeName>
    <deviceName>PlexPCR Flu/RSV/SARS-CoV-2</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>1703192</reference>
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    <tradeName>TRUPCR® TORCH Panel Kit</tradeName>
    <deviceName>TRUPCR® TORCH Panel Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
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    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT177A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:43.313Z</lastUpdated>
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    <tradeName>BIOSYNEX AMPLIQUICK Fecal Virology</tradeName>
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    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
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    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150047_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:03.517Z</lastUpdated>
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    <udiDi>08908015304965</udiDi>
    <basicUdiDi>89080153043B1271L7</basicUdiDi>
    <tradeName>TRUPCR® TORCH Panel Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
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    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1272</reference>
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    <tradeName>TRUPCR® TORCH Panel Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Adenovirus and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <reference>S3335E-48</reference>
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    <lastUpdated>2026-06-28T17:32:37.030Z</lastUpdated>
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    <deviceName>Adenovirus and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3335E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:32.510Z</lastUpdated>
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    <tradeName>BIOSYNEX AMPLIQUICK Fecal Virology</tradeName>
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    <tradeName>BIOSYNEX AMPLIQUICK Fecal Virology</tradeName>
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    <tradeName>EntericBio® Viral Panel 2</tradeName>
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    <manufacturerName>Serosep Limited</manufacturerName>
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    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
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    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
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    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
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