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    <deviceName>Influenza A and B virus nucleic acid test kit  (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <reference>R083T050B0C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:56.992Z</lastUpdated>
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    <tradeName>Panther Fusion Flu A/B/RSV Assay Controls Kit</tradeName>
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    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
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    <tradeName>Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
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    <tradeName>Influenza A+B Rapid Test Cassette</tradeName>
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    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2303TY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:35.570Z</lastUpdated>
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    <tradeName>Panther Fusion Paraflu Assay Controls Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04337</reference>
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    <lastUpdated>2026-06-23T19:31:34.844Z</lastUpdated>
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    <tradeName>VitaPCR Flu A&amp;B Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:33:16.552Z</lastUpdated>
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    <tradeName>Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ04M1</reference>
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    <lastUpdated>2026-06-16T10:13:44.433Z</lastUpdated>
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    <tradeName>Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ04S1</reference>
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    <lastUpdated>2026-06-16T10:13:44.402Z</lastUpdated>
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    <tradeName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT176B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:48:55.724Z</lastUpdated>
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    <tradeName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T09:48:55.711Z</lastUpdated>
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    <tradeName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <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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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT176D</reference>
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    <tradeName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
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    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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