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    <tradeName>MutaPLEX® Blastocystis, PCR</tradeName>
    <deviceName>MutaPLEX® Blastocystis, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>micro-IDent®plus11 VER 1.0</tradeName>
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    <tradeName>micro-IDent® VER 2.0</tradeName>
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    <tradeName>Bacillus Anthracis Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Bacillus Anthracis Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnCode>W0105011699</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT018</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:11.638Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay</tradeName>
    <deviceName>Aptima BV Assay</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>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05186</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:23.772Z</lastUpdated>
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    <tradeName>Lyophilized rabbit plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T00:35:37.089Z</lastUpdated>
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    <tradeName>VIASURE</tradeName>
    <deviceName>VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <tradeName>Aptima BV Assay Calibrator</tradeName>
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    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05188</reference>
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    <lastUpdated>2026-06-23T19:31:32.868Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05186</reference>
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    <lastUpdated>2026-06-23T19:31:32.852Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07662</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:32.813Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay Controls Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-23T19:31:32.791Z</lastUpdated>
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    <tradeName>Aptima BV Assay</tradeName>
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    <manufacturerName>Hologic</manufacturerName>
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    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <emdnCode>W0105011699</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07662</reference>
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    <lastUpdated>2026-06-23T19:31:32.766Z</lastUpdated>
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