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    <udiDi>00857167005009</udiDi>
    <basicUdiDi>0857167005RM0030017M</basicUdiDi>
    <tradeName>ePlex Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenMark Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000010772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RM003001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:13.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857167005382</udiDi>
    <basicUdiDi>085716700510107545001KP</basicUdiDi>
    <tradeName>cobas® eplex system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenMark Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000010772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10107545001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:13.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857167005399</udiDi>
    <basicUdiDi>085716700510246944001PN</basicUdiDi>
    <tradeName>cobas® eplex respiratory pathogen panel 3 (RP3)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenMark Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000010772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10246944001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:18:13.824Z</lastUpdated>
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