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<eudamedExport entity="devices">
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    <udiDi>08809539870083</udiDi>
    <basicUdiDi>B-08809539870083</basicUdiDi>
    <tradeName>BRCAaccuTest PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB112V-012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:32.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870106</udiDi>
    <basicUdiDi>B-08809539870106</basicUdiDi>
    <tradeName>BRCAaccuTest PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB112V-024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:31.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870137</udiDi>
    <basicUdiDi>B-08809539870137</basicUdiDi>
    <tradeName>HEMEaccuTest DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB121V-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:31.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870151</udiDi>
    <basicUdiDi>B-08809539870151</basicUdiDi>
    <tradeName>HEMEaccuTest DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB121V-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:30.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870267</udiDi>
    <basicUdiDi>B-08809539870267</basicUdiDi>
    <tradeName>SOLIDaccuTest DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB131V-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:29.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870281</udiDi>
    <basicUdiDi>B-08809539870281</basicUdiDi>
    <tradeName>SOLIDaccuTest DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB131V-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:24.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870458</udiDi>
    <basicUdiDi>B-08809539870458</basicUdiDi>
    <tradeName>ONCOaccuPanel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB162V-060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:24.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870717</udiDi>
    <basicUdiDi>B-08809539870717</basicUdiDi>
    <tradeName>NGeneAnalySys</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB312VWW</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:15.179Z</lastUpdated>
  </row>
</eudamedExport>