<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TRMF000028405BCR230RTTN</udiDi>
    <basicUdiDi>B-TRMF000028405BCR230RTTN</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 p230(μbcr) Detection Kit, 48T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCR230-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:49.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BCR210RTT8</udiDi>
    <basicUdiDi>B-TRMF000028405BCR210RTT8</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 p210(Mbcr) IS-MMR Detection Kit, 48T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCR210-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:48.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BCR190RTUM</udiDi>
    <basicUdiDi>B-TRMF000028405BCR190RTUM</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 p190(mbcr) Detection Kit, 48T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCR190-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:47.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405B51RT50X7</udiDi>
    <basicUdiDi>B-TRMF000028405B51RT50X7</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HLA-B*51 Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B51-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:43.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405B27RT50Y2</udiDi>
    <basicUdiDi>B-TRMF000028405B27RT50Y2</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HLA-B*27 Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B27-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:42.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405AML1RT244V</udiDi>
    <basicUdiDi>B-TRMF000028405AML1RT244V</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP RUNX1-RUNX1T1 t(8;21) Detection Kit, 24T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AML1-RT24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:42.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-STP-xxxQP</udiDi>
    <basicUdiDi>B-STP-xxxQP</basicUdiDi>
    <tradeName>DNA in situ Hybridization Reagents</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CytoTest Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000054699</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-xxx</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:45:50.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270376</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ FCL SE50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002752-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:42.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270321</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ FCL SE50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002752-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:42.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270383</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002751-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:20.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270314</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002751-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:20.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270390</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCL SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002765-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:20.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270307</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCL SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002765-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:19.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270406</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCL SE50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002768-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:19.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270338</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ FCL SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002764-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:16.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-READY17660AB</udiDi>
    <basicUdiDi>B-READY17660AB</basicUdiDi>
    <tradeName>beREADY test</tradeName>
    <deviceName>beREADY test</deviceName>
    <manufacturerName>Celvia CC AS</manufacturerName>
    <manufacturerSrn>EE-MF-000045569</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>beREADY test</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:26:59.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA013UJ</udiDi>
    <basicUdiDi>B-RA013UJ</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>Cervical Cancer Methylation Test</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122-07048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:55.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629924602</udiDi>
    <basicUdiDi>803362992PHARMAGENPLUSFB</basicUdiDi>
    <tradeName>08033629924602</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA187/10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:55:19.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270352</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002760-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:46:25.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975996270345</udiDi>
    <basicUdiDi>697599627S-Kit35</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen MGI Biological Electronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044825</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002760-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:46:25.384Z</lastUpdated>
  </row>
</eudamedExport>