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    <tradeName>Ora-3D</tradeName>
    <deviceName>Ora-3D</deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9000006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:53.225Z</lastUpdated>
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  <row>
    <udiDi>00850050841005</udiDi>
    <basicUdiDi>086000093094000005S5</basicUdiDi>
    <tradeName>OraFusion Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4000005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:20.660Z</lastUpdated>
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    <udiDi>00860000930963</udiDi>
    <basicUdiDi>086000093099000002UL</basicUdiDi>
    <tradeName>BeVigilant™ Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9000002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:56.246Z</lastUpdated>
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    <basicUdiDi>086000093099000011UM</basicUdiDi>
    <tradeName>BeVigilant™ Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9000011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:56.220Z</lastUpdated>
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