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    <deviceName>Genedrive® CYP2C19 Control Kit</deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
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    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>CYP2C19-CTRL10</reference>
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    <lastUpdated>2026-07-01T23:30:03.675Z</lastUpdated>
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    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName>Genedrive® CYP2C19 ID Kit</deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
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    <tradeName>Yourgene® DPYD</tradeName>
    <deviceName>Yourgene® DPYD</deviceName>
    <manufacturerName>Yourgene Health UK Ltd</manufacturerName>
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    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>08595223925411</udiDi>
    <basicUdiDi>85952239000016X9</basicUdiDi>
    <tradeName>gb PHARM CYP2C19</tradeName>
    <deviceName>gb PHARM CYP2C19</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106030104</emdnCode>
    <emdnDescription>CYP2C19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3254-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:13.650Z</lastUpdated>
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    <udiDi>08437016942499</udiDi>
    <basicUdiDi>8437016942GVS-C06LU</basicUdiDi>
    <tradeName>Genvinset® HLA C*06 48 tests</tradeName>
    <deviceName>Genvinset® HLA C*06</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-C06-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:44.819Z</lastUpdated>
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    <basicUdiDi>8437016942GVS-C06LU</basicUdiDi>
    <tradeName>Genvinset® HLA C*06 24 tests</tradeName>
    <deviceName>Genvinset® HLA C*06</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:43.618Z</lastUpdated>
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    <udiDi>05060654860851</udiDi>
    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-PL</reference>
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    <lastUpdated>2026-06-19T21:44:07.008Z</lastUpdated>
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    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-PL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:44:06.118Z</lastUpdated>
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    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-TR</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:55.305Z</lastUpdated>
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    <udiDi>05060654860653</udiDi>
    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-PT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:54.404Z</lastUpdated>
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    <udiDi>05060654860646</udiDi>
    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:53.546Z</lastUpdated>
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    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-EL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:52.596Z</lastUpdated>
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    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-IT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:51.699Z</lastUpdated>
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    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-ES</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:50.802Z</lastUpdated>
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    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-NL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:49.903Z</lastUpdated>
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    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-FR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:49.016Z</lastUpdated>
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    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-TR</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:47.201Z</lastUpdated>
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    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
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    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-PT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:46.309Z</lastUpdated>
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    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:45.399Z</lastUpdated>
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    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-EL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:44.569Z</lastUpdated>
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