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    <tradeName>gb GENETIC HFE</tradeName>
    <deviceName>gb GENETIC HFE</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3208-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:32:58.455Z</lastUpdated>
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    <udiDi>08595223920614</udiDi>
    <basicUdiDi>85952239000003WY</basicUdiDi>
    <tradeName>gb GENETIC APOE</tradeName>
    <deviceName>gb GENETIC APOE</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
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    <emdnDescription>ATHEROSCLEROSIS</emdnDescription>
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    <reference>3206-025</reference>
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    <udiDi>08033629924473</udiDi>
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    <tradeName>08033629924473</tradeName>
    <deviceName>CF FAST</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA1358/48A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>NIFTY®</tradeName>
    <deviceName>Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030110, MFG030111, MFG030112</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:07:48.306Z</lastUpdated>
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    <udiDi>00856826006098</udiDi>
    <basicUdiDi>0856826006902420G9</basicUdiDi>
    <tradeName>CytoScan Dx Array, 6 pk</tradeName>
    <deviceName>CytoScan Dx Assay, a part of CytoScan™ Dx Test</deviceName>
    <manufacturerName>Affymetrix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000028847</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902150 (902420)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:41:39.997Z</lastUpdated>
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    <udiDi>00850017493124</udiDi>
    <basicUdiDi>0850017493A011248A</basicUdiDi>
    <tradeName>AmplideX Fragile X Dx &amp; Carrier Screen Kit</tradeName>
    <deviceName>AmplideX Fragile X Dx &amp; Carrier Screen Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A01124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:15:37.531Z</lastUpdated>
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    <udiDi>00816270020194</udiDi>
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    <tradeName>VeriSeq™ NIPT v2 Assay Software</tradeName>
    <deviceName>VeriSeq™ NIPT Assay Software</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20047024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:44.127Z</lastUpdated>
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    <udiDi>00816270020163</udiDi>
    <basicUdiDi>0081627002NIPTRP</basicUdiDi>
    <tradeName>VeriSeq™ NIPT Sample Preparation Kit (24 samples)</tradeName>
    <deviceName>VeriSeq™ NIPT Sample Preparation Kit</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20025895</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:43.317Z</lastUpdated>
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    <udiDi>00816270020149</udiDi>
    <basicUdiDi>0081627002CYSTFIB8C</basicUdiDi>
    <tradeName>TruSight™ Cystic Fibrosis Library Prep</tradeName>
    <deviceName>TruSight™ Cystic Fibrosis</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20036925</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:41.713Z</lastUpdated>
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    <udiDi>+G2860230Z</udiDi>
    <basicUdiDi>++G286LongRangeNGS7K</basicUdiDi>
    <tradeName>H-Seq-LR-NGS Sequenzierungskit für 48 Typisierungen</tradeName>
    <deviceName>H-Seq-LR-NGS 48 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:57.076Z</lastUpdated>
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    <udiDi>+G2860140Z</udiDi>
    <basicUdiDi>++G286HSeqNGSP9</basicUdiDi>
    <tradeName>H-Seq-NGS Sequenzierungskit für 7x768 Typisierungen</tradeName>
    <deviceName>H-Seq-NGS Sequenzierungskit für 7x768 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:50.917Z</lastUpdated>
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  <row>
    <udiDi>+G2860010V</udiDi>
    <basicUdiDi>++G286HSeqABCKR</basicUdiDi>
    <tradeName>H-Seq-ABC Sequenzierungskit für 48 Typisierungen</tradeName>
    <deviceName>H-Seq-ABC Sequenzierungskit für 48 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:46.086Z</lastUpdated>
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    <udiDi>D-USMF000054278BMCXJ020HP</udiDi>
    <basicUdiDi>B-USMF000054278BMCXJ020HP</basicUdiDi>
    <tradeName>Sickle SCAN Test</tradeName>
    <deviceName>Sickle SCAN Test</deviceName>
    <manufacturerName>BioMedomics</manufacturerName>
    <manufacturerSrn>US-MF-000054278</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CXJ020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:09:35.214Z</lastUpdated>
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    <udiDi>D-TRMF000028405THRRT50T6</udiDi>
    <basicUdiDi>B-TRMF000028405THRRT50T6</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>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THR-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:36.558Z</lastUpdated>
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    <udiDi>D-TRMF000028405THR6RT50HP</udiDi>
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    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP Thrombophilia P., 50T (FII, FVL,MTHFR677, MTHFR1298, PAI,FXIII)</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>THR6-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:35.873Z</lastUpdated>
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    <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>
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    <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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    <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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    <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>
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