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<eudamedExport entity="devices">
  <row>
    <udiDi>D-TRMF000028405FMFRT50HM</udiDi>
    <basicUdiDi>B-TRMF000028405FMFRT50HM</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP FMF 11 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>FMF-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:27.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405FMF5RT506T</udiDi>
    <basicUdiDi>B-TRMF000028405FMF5RT506T</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP FMF 5 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>FMF.5-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:27.167Z</lastUpdated>
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  <row>
    <udiDi>D-JGM10201NW-50TH4</udiDi>
    <basicUdiDi>B-JGM10201NW-50TH4</basicUdiDi>
    <tradeName>Survival Motor Neuron 1 (SMN1) Gene Detection Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JGM10201NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:30.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JGM10201NW-25TH4</udiDi>
    <basicUdiDi>B-JGM10201NW-25TH4</basicUdiDi>
    <tradeName>Survival Motor Neuron 1 (SMN1) Gene Detection Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JGM10201NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:29.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3300196W9</udiDi>
    <basicUdiDi>B-CNMF000049232R3300196W9</basicUdiDi>
    <tradeName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R33001-096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:09.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3300148VW</udiDi>
    <basicUdiDi>B-CNMF000049232R3300148VW</basicUdiDi>
    <tradeName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R33001-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:08.383Z</lastUpdated>
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  <row>
    <udiDi>D-9021B6</udiDi>
    <basicUdiDi>B-9021B6</basicUdiDi>
    <tradeName>D-9021B6</tradeName>
    <deviceName>Partner and Localiser of BRCA2 (PALB2) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-PALB096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:05.316Z</lastUpdated>
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  <row>
    <udiDi>D-86804222814035R</udiDi>
    <basicUdiDi>B-86804222814035R</basicUdiDi>
    <tradeName>IntRaFast-Q SMA SCREENING KIT</tradeName>
    <deviceName>IntRaFast-Q SMA SCREENING KIT</deviceName>
    <manufacturerName>SNP BİYOTEKNOLOJİ ARAŞTIRMA GELİŞTİRME VE ÜRETİM SANAYİ VE TİCARET LİMİTED ŞİRKETİLİMİTED</manufacturerName>
    <manufacturerSrn>TR-MF-000036548</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>200R-40-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T08:18:27.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773151WMFN</udiDi>
    <basicUdiDi>B-84295773151WMFN</basicUdiDi>
    <tradeName>YChromStrip</tradeName>
    <deviceName>YChromStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</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>3.151.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:26.935Z</lastUpdated>
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  <row>
    <udiDi>08809240103906</udiDi>
    <basicUdiDi>B-08809240103906</basicUdiDi>
    <tradeName>Anyplex™ II Thrombosis SNP Panel Assay</tradeName>
    <deviceName>Anyplex™ II Thrombosis SNP Panel Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS10390Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:01.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240100417</udiDi>
    <basicUdiDi>B-08809240100417</basicUdiDi>
    <tradeName>Anyplex™ II Thrombosis SNP Panel Assay</tradeName>
    <deviceName>Anyplex™ II Thrombosis SNP Panel Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS7600X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:59.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240100400</udiDi>
    <basicUdiDi>B-08809240100400</basicUdiDi>
    <tradeName>Anyplex™ II Thrombosis SNP Panel Assay</tradeName>
    <deviceName>Anyplex™ II Thrombosis SNP Panel Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS7600Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:58.132Z</lastUpdated>
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  <row>
    <udiDi>08595696304294</udiDi>
    <basicUdiDi>B-08595696304294</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Factor XIII V34L PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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>A58422</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:29.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302696</udiDi>
    <basicUdiDi>B-08595696302696</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:55.925Z</lastUpdated>
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  <row>
    <udiDi>08594161959915</udiDi>
    <basicUdiDi>B-08594161959915</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:39.389Z</lastUpdated>
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  <row>
    <udiDi>08594161958529</udiDi>
    <basicUdiDi>B-08594161958529</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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/MC/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:35.377Z</lastUpdated>
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  <row>
    <udiDi>08594161956983</udiDi>
    <basicUdiDi>B-08594161956983</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:02.645Z</lastUpdated>
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  <row>
    <udiDi>08437016942338</udiDi>
    <basicUdiDi>B-08437016942338</basicUdiDi>
    <tradeName>Adellgene®  Myotonic Dystrophy Screening 16 tests</tradeName>
    <deviceName>Adellgene® Myotonic Dystrophy Screening 16 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</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>AD-MD-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:28.771Z</lastUpdated>
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    <udiDi>08436589881853</udiDi>
    <basicUdiDi>B-08436589881853</basicUdiDi>
    <tradeName>Inherited CardioKitDx</tradeName>
    <deviceName>Inherited CardioKitDx</deviceName>
    <manufacturerName>Health in Code, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000054848</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>IMG-390</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:50:54.180Z</lastUpdated>
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    <udiDi>08057723370615</udiDi>
    <basicUdiDi>B-08057723370615</basicUdiDi>
    <tradeName>08057723370615</tradeName>
    <deviceName>SMART SNP MTHFR 1298 Positive Control</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</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>SNPD-032 CTRL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:31.848Z</lastUpdated>
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</eudamedExport>