<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TRMF000028405HERRT24KJ</udiDi>
    <basicUdiDi>B-TRMF000028405HERRT24KJ</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HER-2 Expression Analysis 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>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HER-RT24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:34.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405FLT3RT25BB</udiDi>
    <basicUdiDi>B-TRMF000028405FLT3RT25BB</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP FLT3 D835Y Mutation Detection Kit, 25T</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>FLT3-RT25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:26.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405FLT3FA255Q</udiDi>
    <basicUdiDi>B-TRMF000028405FLT3FA255Q</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP FLT3 ITD/D835Y Mutation Detection Kit, 25T</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>FLT3-FA25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:22.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405FIP1RT247C</udiDi>
    <basicUdiDi>B-TRMF000028405FIP1RT247C</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP FIP1L1-PDGFRA 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>FIP1-RT24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:21.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405E2ART244S</udiDi>
    <basicUdiDi>B-TRMF000028405E2ART244S</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP TCF3/PBX1 t(1;19) 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>E2A-RT24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:19.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405CBFRT24BJ</udiDi>
    <basicUdiDi>B-TRMF000028405CBFRT24BJ</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP CBFB-MYH11 Inv(16) 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>W01060211</emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBF-RT24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:54.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BCRSCRRTF7</udiDi>
    <basicUdiDi>B-TRMF000028405BCRSCRRTF7</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP BCR-ABL1 (p190, p210, p230) Screening 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>BCRSCR-RT48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:50.155Z</lastUpdated>
  </row>
  <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-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-KLM-300110;KLM-300190XX</udiDi>
    <basicUdiDi>B-KLM-300110;KLM-300190XX</basicUdiDi>
    <tradeName>Colosafe</tradeName>
    <deviceName>Methylation Detection Kit for Human SDC2 Gene (Real Time PCR)</deviceName>
    <manufacturerName>Creative Biosciences (Guangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034058</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>KLM-300110；KLM-300190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:40:22.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MPC06001MV</udiDi>
    <basicUdiDi>B-G2MPC06001MV</basicUdiDi>
    <tradeName>Pan Cancer Panel</tradeName>
    <deviceName>Pan Cancer Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MPC06001-ill,G2MPC06001-MG, G2MPC06001-TF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:13.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MOC01001L9</udiDi>
    <basicUdiDi>B-G2MOC01001L9</basicUdiDi>
    <tradeName>Onco Check Panel</tradeName>
    <deviceName>Onco Check Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MOC01001-ill; G2MOC01001-TF; G2MOC01001-MG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:08.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MML28001R3</udiDi>
    <basicUdiDi>B-G2MML28001R3</basicUdiDi>
    <tradeName>Myeloid Leukemia NGS Panel</tradeName>
    <deviceName>Myeloid Leukemia NGS Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MML28001-ill, G2MML28001-MG, G2MML28001-TF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:52.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MLYM31001YM</udiDi>
    <basicUdiDi>B-G2MLYM31001YM</basicUdiDi>
    <tradeName>Lymphoma NGS Panel</tradeName>
    <deviceName>Lymphoma NGS Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MLYM31001-ill, G2MLYM31001-MG, G2MLYM31001-TF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:50.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MLL30001P5</udiDi>
    <basicUdiDi>B-G2MLL30001P5</basicUdiDi>
    <tradeName>Lymphoid Leukemia NGS Panel</tradeName>
    <deviceName>Lymphoid Leukemia NGS Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MLL30001-ill, G2MLL30001-MG, G2MLL30001-TF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:50.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MCTLP1300154</udiDi>
    <basicUdiDi>B-G2MCTLP1300154</basicUdiDi>
    <tradeName>ctDNA Lung Panel</tradeName>
    <deviceName>ctDNA Lung Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MCTLP13001-ill,G2MCTLP13001-MG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:44.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MCTCP11001XS</udiDi>
    <basicUdiDi>B-G2MCTCP11001XS</basicUdiDi>
    <tradeName>ctDNA Colorectal Panel</tradeName>
    <deviceName>ctDNA Colorectal Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MCTCP11001-ill, G2MCTCP11001-MG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:42.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MCTBP12001XG</udiDi>
    <basicUdiDi>B-G2MCTBP12001XG</basicUdiDi>
    <tradeName>ctDNA Breast Panel</tradeName>
    <deviceName>ctDNA Breast Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2MCTBP12001-ill,G2MCTBP12001-MG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:42.009Z</lastUpdated>
  </row>
</eudamedExport>