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    <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>
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    <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>
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    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <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>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <lastUpdated>2026-07-17T19:39:10.140Z</lastUpdated>
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    <udiDi>08436615250103</udiDi>
    <basicUdiDi>843661525GVS-B51N4</basicUdiDi>
    <tradeName>Genvinset® HLA B51 48 test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-B51-48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:37:53.158Z</lastUpdated>
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    <udiDi>D-A070D4</udiDi>
    <basicUdiDi>B-A070D4</basicUdiDi>
    <tradeName>D-A070D4</tradeName>
    <deviceName>PHASIFY™ Endometrial Cancer Methylation Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>PHASIFY™ Endometrial Cancer Methylation Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:26.604Z</lastUpdated>
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    <udiDi>D-A068DH</udiDi>
    <basicUdiDi>B-A068DH</basicUdiDi>
    <tradeName>D-A068DH</tradeName>
    <deviceName>PHASIFY™ HPV PCR Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHASIFY™ HPV PCR Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:24.649Z</lastUpdated>
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    <udiDi>D-A069DK</udiDi>
    <basicUdiDi>B-A069DK</basicUdiDi>
    <tradeName>D-A069DK</tradeName>
    <deviceName>PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR Test</reference>
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    <lastUpdated>2026-07-17T01:43:24.567Z</lastUpdated>
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    <udiDi>D-5713915SS014VCRK</udiDi>
    <basicUdiDi>B-5713915SS014VCRK</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid KIT qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5800; 5581</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:02.747Z</lastUpdated>
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    <udiDi>D-5713915SS013VARA</udiDi>
    <basicUdiDi>B-5713915SS013VARA</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE KIT qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1154; 1846</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:01.485Z</lastUpdated>
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    <udiDi>D-5713915SS010V4Q3</udiDi>
    <basicUdiDi>B-5713915SS010V4Q3</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid PIK3CA qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</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>5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:01.366Z</lastUpdated>
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    <udiDi>D-5713915SS007VFRZ</udiDi>
    <basicUdiDi>B-5713915SS007VFRZ</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE NRAS qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:57.556Z</lastUpdated>
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    <udiDi>D-5713915SS004V9QS</udiDi>
    <basicUdiDi>B-5713915SS004V9QS</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid EGFR qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:57.400Z</lastUpdated>
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    <udiDi>D-5713915SS005VBRF</udiDi>
    <basicUdiDi>B-5713915SS005VBRF</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE KRAS qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1900;1701;1905;1706;1910;1711;1915;1716;1925;1726;1930;1731;1940;1741;1945;1746;1955;1756;1960;1761</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:55.304Z</lastUpdated>
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    <udiDi>D-5713915SS003V7QH</udiDi>
    <basicUdiDi>B-5713915SS003V7QH</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE EGFR qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:55.237Z</lastUpdated>
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    <udiDi>D-5713915SS002V5Q8</udiDi>
    <basicUdiDi>B-5713915SS002V5Q8</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid BRAF qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:37.298Z</lastUpdated>
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    <udiDi>D-5713915SS001V3PX</udiDi>
    <basicUdiDi>B-5713915SS001V3PX</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE BRAF qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:36.416Z</lastUpdated>
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    <udiDi>D-529012PL</udiDi>
    <basicUdiDi>B-529012PL</basicUdiDi>
    <tradeName>D-529012PL</tradeName>
    <deviceName>Real time PCR Kit for Monkeypox Virus</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <reference>529012/529013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:52.371Z</lastUpdated>
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    <tradeName>iDNA PGx CNS kit</tradeName>
    <deviceName>iDNA PGx CNS</deviceName>
    <manufacturerName>iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ref.002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:36:04.287Z</lastUpdated>
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    <basicUdiDi>B-52004235002160</basicUdiDi>
    <tradeName>iDNA Cardio Health</tradeName>
    <deviceName>iDNA Cardio Health</deviceName>
    <manufacturerName>iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ</manufacturerName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ref.005</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:34:16.013Z</lastUpdated>
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    <udiDi>07332940008390</udiDi>
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    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® NPM1 Mutation</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXNPM1-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:15.392Z</lastUpdated>
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