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<eudamedExport entity="devices">
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    <udiDi>00810173657006</udiDi>
    <basicUdiDi>B-00810173657006</basicUdiDi>
    <tradeName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</tradeName>
    <deviceName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7001D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:52.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656993</udiDi>
    <basicUdiDi>B-00810173656993</basicUdiDi>
    <tradeName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</tradeName>
    <deviceName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7001C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:50.801Z</lastUpdated>
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    <udiDi>08720211481376</udiDi>
    <basicUdiDi>872021148P1025D</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
    <deviceName>SALSA MLPA Probemix P102 HBB</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P102-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:23:40.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211481383</udiDi>
    <basicUdiDi>872021148P1025D</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P102-050R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:57:51.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211481390</udiDi>
    <basicUdiDi>872021148P1025D</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P102-100R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:57:49.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480799</udiDi>
    <basicUdiDi>872021148P0565X</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P056 TP53</tradeName>
    <deviceName>SALSA MLPA Probemix P056 TP53</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P056-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:16:21.549Z</lastUpdated>
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  <row>
    <udiDi>08720211480805</udiDi>
    <basicUdiDi>872021148P0565X</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P056 TP53</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P056-050R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:21.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480812</udiDi>
    <basicUdiDi>872021148P0565X</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P056 TP53</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P056-100R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:19.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480850</udiDi>
    <basicUdiDi>872021148P0625S</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P062 LDLR</tradeName>
    <deviceName>SALSA MLPA Probemix P062 LDLR</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P062-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:56:12.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480614</udiDi>
    <basicUdiDi>872021148P0455S</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P045 BRCA2/CHEK2</tradeName>
    <deviceName>SALSA MLPA Probemix P045 BRCA2/CHEK2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P045-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:56:10.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480621</udiDi>
    <basicUdiDi>872021148P0455S</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P045 BRCA2/CHEK2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P045-050R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:11.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480638</udiDi>
    <basicUdiDi>872021148P0455S</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P045 BRCA2/CHEK2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P045-100R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:11.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480867</udiDi>
    <basicUdiDi>872021148P0625S</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P062 LDLR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P062-050R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:10.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480874</udiDi>
    <basicUdiDi>872021148P0625S</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P062 LDLR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P062-100R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:10.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211480263</udiDi>
    <basicUdiDi>872021148P0155H</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P015 MECP2</tradeName>
    <deviceName>SALSA MLPA Probemix P015 MECP2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P015-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:39:41.707Z</lastUpdated>
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  <row>
    <udiDi>D-TRMF000028405SMN1MRT5J5</udiDi>
    <basicUdiDi>B-TRMF000028405SMN1MRT5J5</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP SMN1 Exon7/8 Screening 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMN1M-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:25.999Z</lastUpdated>
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    <udiDi>D-TRMF000028405PAIRT50K4</udiDi>
    <basicUdiDi>B-TRMF000028405PAIRT50K4</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP PAI-1 4G/5G Mutation 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAI-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:02.608Z</lastUpdated>
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    <udiDi>D-TRMF000028405MTHFIRT5MU</udiDi>
    <basicUdiDi>B-TRMF000028405MTHFIRT5MU</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTHFR C677T Mutation 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTHFI-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:55.170Z</lastUpdated>
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  <row>
    <udiDi>D-TRMF000028405MTHFIIRTN5</udiDi>
    <basicUdiDi>B-TRMF000028405MTHFIIRTN5</basicUdiDi>
    <tradeName>geneMap</tradeName>
    <deviceName>geneMAPTM MTHFR A1298C Mutation 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTHFII-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:53.588Z</lastUpdated>
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  <row>
    <udiDi>D-TRMF000028405FXIIIRT5M9</udiDi>
    <basicUdiDi>B-TRMF000028405FXIIIRT5M9</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP FXIII Mutation 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXIII-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:32.777Z</lastUpdated>
  </row>
</eudamedExport>