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    <udiDi>15415219001328</udiDi>
    <basicUdiDi>5415219A0220BV</basicUdiDi>
    <tradeName>Idylla™ CDx MSI Test</tradeName>
    <deviceName>Idylla™ CDx MSI Test</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0220/6</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:05:30.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219001390</udiDi>
    <basicUdiDi>5415219P1030H2</basicUdiDi>
    <tradeName>Idylla™ Hub</tradeName>
    <deviceName>Idylla™ Hub</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1030</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:03:17.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219001178</udiDi>
    <basicUdiDi>5415219P2040HC</basicUdiDi>
    <tradeName>Idylla™ Console Software Plus (CSW+)</tradeName>
    <deviceName>Idylla™ Console Software Plus (CSW+)</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2040</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:03:16.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219000843</udiDi>
    <basicUdiDi>5415219A0270CC</basicUdiDi>
    <tradeName>Idylla™ EGFR Mutation Test</tradeName>
    <deviceName>Idylla™ EGFR Mutation Test</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0270/6</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:03:14.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219000126</udiDi>
    <basicUdiDi>5415219P1010GU</basicUdiDi>
    <tradeName>Idylla™ Console</tradeName>
    <deviceName>Idylla™ Console</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:03:13.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219000119</udiDi>
    <basicUdiDi>5415219P0010GM</basicUdiDi>
    <tradeName>Idylla™ Instrument</tradeName>
    <deviceName>Idylla™ Instrument</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P0010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:03:13.061Z</lastUpdated>
  </row>
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