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    <tradeName>gb PHARM DPYD</tradeName>
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    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:22.050Z</lastUpdated>
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    <tradeName>gb PHARM DPYD</tradeName>
    <deviceName>gb PHARM DPYD</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
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    <udiDi>08595223925022</udiDi>
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    <tradeName>gb PHARM Warfarin</tradeName>
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    <udiDi>08595223925015</udiDi>
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    <tradeName>gb PHARM Warfarin</tradeName>
    <deviceName>gb PHARM Warfarin</deviceName>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:06.437Z</lastUpdated>
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    <udiDi>08595223921727</udiDi>
    <basicUdiDi>85952239000018XD</basicUdiDi>
    <tradeName>gb PHARM TPMT</tradeName>
    <deviceName>gb PHARM TPMT</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3217-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:04.029Z</lastUpdated>
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    <udiDi>08595223921710</udiDi>
    <basicUdiDi>85952239000018XD</basicUdiDi>
    <tradeName>gb PHARM TPMT</tradeName>
    <deviceName>gb PHARM TPMT</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:02.848Z</lastUpdated>
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    <udiDi>08437016942666</udiDi>
    <basicUdiDi>8437016942GVS-B5CF</basicUdiDi>
    <tradeName>Genvinset® HLA Behçet v5 48 tests</tradeName>
    <deviceName>Genvinset® HLA Behçet v5</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-B505-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:05.232Z</lastUpdated>
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    <udiDi>08437016942659</udiDi>
    <basicUdiDi>8437016942GVS-B5CF</basicUdiDi>
    <tradeName>Genvinset® HLA Behçet v5 24 tests</tradeName>
    <deviceName>Genvinset® HLA Behçet v5</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
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    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:04.032Z</lastUpdated>
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    <udiDi>08437016942642</udiDi>
    <basicUdiDi>8437016942GVS-B27LX</basicUdiDi>
    <tradeName>Genvinset® HLA B27v5 48 tests</tradeName>
    <deviceName>Genvinset® HLA B27v5</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
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    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-B2705-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:58.044Z</lastUpdated>
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    <udiDi>08437016942635</udiDi>
    <basicUdiDi>8437016942GVS-B27LX</basicUdiDi>
    <tradeName>Genvinset® HLA B27v5 24 tests</tradeName>
    <deviceName>Genvinset® HLA B27v5</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:56.931Z</lastUpdated>
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    <udiDi>08437016942536</udiDi>
    <basicUdiDi>8437016942GVS-LACQH</basicUdiDi>
    <tradeName>Genvinset® Lactose Intolerance 48 tests</tradeName>
    <deviceName>Genvinset® Lactose Intolerance</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-LAC-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:54.428Z</lastUpdated>
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    <udiDi>08437016942529</udiDi>
    <basicUdiDi>8437016942GVS-LACQH</basicUdiDi>
    <tradeName>Genvinset® Lactose Intolerance 24 tests</tradeName>
    <deviceName>Genvinset® Lactose Intolerance</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-LAC-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:53.228Z</lastUpdated>
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    <udiDi>08437016942512</udiDi>
    <basicUdiDi>8437016942GVS-DQPRK</basicUdiDi>
    <tradeName>Genvinset® HLA Celiac Plus 48 tests</tradeName>
    <deviceName>Genvinset® HLA Celiac Plus</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DQP-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:47.219Z</lastUpdated>
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    <udiDi>08437016942505</udiDi>
    <basicUdiDi>8437016942GVS-DQPRK</basicUdiDi>
    <tradeName>Genvinset® HLA Celiac Plus 24 tests</tradeName>
    <deviceName>Genvinset® HLA Celiac Plus</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DQP-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:46.039Z</lastUpdated>
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    <udiDi>08437016942161</udiDi>
    <basicUdiDi>8437016942GVS-NPF7</basicUdiDi>
    <tradeName>Genvinset® HLA Narcolepsy 48 tests</tradeName>
    <deviceName>Genvinset® HLA Narcolepsy</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:14.901Z</lastUpdated>
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    <udiDi>08437016942154</udiDi>
    <basicUdiDi>8437016942GVS-NPF7</basicUdiDi>
    <tradeName>Genvinset® HLA Narcolepsy 24 tests</tradeName>
    <deviceName>Genvinset® HLA Narcolepsy</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
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    <lastUpdated>2026-06-30T12:35:12.398Z</lastUpdated>
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    <udiDi>08437016942123</udiDi>
    <basicUdiDi>8437016942GVS-A29LW</basicUdiDi>
    <tradeName>Genvinset® HLA A29 48 tests</tradeName>
    <deviceName>Genvinset® HLA A29</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:06.392Z</lastUpdated>
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    <tradeName>Genvinset® HLA A29 24 tests</tradeName>
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    <lastUpdated>2026-06-30T12:35:05.280Z</lastUpdated>
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    <tradeName>Genvinset® HLA Celiac 48 tests</tradeName>
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    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
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    <emdnDescription>HLA-TYPING</emdnDescription>
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    <lastUpdated>2026-06-30T12:35:03.996Z</lastUpdated>
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    <basicUdiDi>8437016942GVS-DQEB</basicUdiDi>
    <tradeName>Genvinset® HLA Celiac 24 tests</tradeName>
    <deviceName>Genvinset® HLA Celiac</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DQ-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:02.806Z</lastUpdated>
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