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    <tradeName>Genvinset® Thrombo panel 24 test</tradeName>
    <deviceName>Genvinset® Thrombo panel</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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-THP-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:03.990Z</lastUpdated>
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    <udiDi>08436615250028</udiDi>
    <basicUdiDi>843661525GVS-PAI/F13UA</basicUdiDi>
    <tradeName>Genvinset® PAI-1/FXIII multiplex 96 test</tradeName>
    <deviceName>Genvinset® PAI-1/FXIII multiplex</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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI/F13-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:02.776Z</lastUpdated>
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    <udiDi>08436615250011</udiDi>
    <basicUdiDi>843661525GVS-PAI/F13UA</basicUdiDi>
    <tradeName>Genvinset® PAI-1/FXIII multiplex 48 test</tradeName>
    <deviceName>Genvinset® PAI-1/FXIII multiplex</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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI/F13-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:01.685Z</lastUpdated>
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    <udiDi>08436615250004</udiDi>
    <basicUdiDi>843661525GVS-PAI/F13UA</basicUdiDi>
    <tradeName>Genvinset® PAI-1/FXIII multiplex 24 test</tradeName>
    <deviceName>Genvinset® PAI-1/FXIII multiplex</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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI/F13-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:33:54.355Z</lastUpdated>
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    <udiDi>08057680910909</udiDi>
    <basicUdiDi>805768091GlutenDQ_02E3</basicUdiDi>
    <tradeName>Gluten DQuick DResolution v4</tradeName>
    <deviceName>Gluten DQuick DResolution v4</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</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>RT-59v4_96</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:53.508Z</lastUpdated>
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    <udiDi>08057680910893</udiDi>
    <basicUdiDi>805768091GlutenDQ_02E3</basicUdiDi>
    <tradeName>Gluten DQuick DResolution v4</tradeName>
    <deviceName>Gluten DQuick DResolution v4</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</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>RT-59v4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:52.302Z</lastUpdated>
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    <udiDi>08057680910763</udiDi>
    <basicUdiDi>805768091DPYD_01XD</basicUdiDi>
    <tradeName>DPYD (5 gene mutations)</tradeName>
    <deviceName>DPYD (5 gene mutations)</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:46.302Z</lastUpdated>
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    <udiDi>08057680910497</udiDi>
    <basicUdiDi>805768091FVG1691_M01CH</basicUdiDi>
    <tradeName>Duplicα RealTime Mix &amp; Match Factor V G1691A Kit QS</tradeName>
    <deviceName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EER038032QS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:45.099Z</lastUpdated>
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    <udiDi>08057680910015</udiDi>
    <basicUdiDi>805768091FVG1691_M01CH</basicUdiDi>
    <tradeName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</tradeName>
    <deviceName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EER038032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:43.900Z</lastUpdated>
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    <udiDi>08057289091238</udiDi>
    <basicUdiDi>8057289090403CNGX037XY</basicUdiDi>
    <tradeName>Myriapod NGS PGx Sign panel</tradeName>
    <deviceName>Myriapod NGS PGx Sign panel</deviceName>
    <manufacturerName>DIATECH PHARMACOGENETICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000018670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGX037</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:25.893Z</lastUpdated>
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    <udiDi>08028169208916</udiDi>
    <basicUdiDi>802816920CW01060402055E</basicUdiDi>
    <tradeName>Eu-Gen MTHFR Dual-Type (25 Test)</tradeName>
    <deviceName>Eu-Gen MTHFR Dual-Type (100 Test)/(25 Test)</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9463S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:25.590Z</lastUpdated>
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    <udiDi>08028169208909</udiDi>
    <basicUdiDi>802816920CW01060402055E</basicUdiDi>
    <tradeName>Eu-Gen MTHFR Dual-Type (100 Test)</tradeName>
    <deviceName>Eu-Gen MTHFR Dual-Type (100 Test)/(25 Test)</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9463</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:24.637Z</lastUpdated>
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    <udiDi>08028169208404</udiDi>
    <basicUdiDi>802816920CW01060402045C</basicUdiDi>
    <tradeName>Eu-Gen FII/FV Type (25 T)</tradeName>
    <deviceName>Eu-Gen FII/FV Type</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9462S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:23.191Z</lastUpdated>
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    <udiDi>08028169208275</udiDi>
    <basicUdiDi>802816920CW01060402045C</basicUdiDi>
    <tradeName>Eu-Gen FII/FV Type</tradeName>
    <deviceName>Eu-Gen FII/FV Type</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9462</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:22.303Z</lastUpdated>
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    <udiDi>08028169205786</udiDi>
    <basicUdiDi>802816920CW010604020258</basicUdiDi>
    <tradeName>LactoGen Controls</tradeName>
    <deviceName>LactoGen</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9242</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:16.233Z</lastUpdated>
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    <udiDi>08028169205779</udiDi>
    <basicUdiDi>802816920CW010604020258</basicUdiDi>
    <tradeName>LactoGen</tradeName>
    <deviceName>LactoGen</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9241</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:14.811Z</lastUpdated>
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    <udiDi>08028169203454</udiDi>
    <basicUdiDi>802816920CW01060402035A</basicUdiDi>
    <tradeName>Xeligen® XL</tradeName>
    <deviceName>Xeligen® XL</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9186</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:13.968Z</lastUpdated>
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    <udiDi>07350040635209</udiDi>
    <basicUdiDi>7350040638R117RJ</basicUdiDi>
    <tradeName>Devyser Thalassemia v2</tradeName>
    <deviceName>Devyser Thalassemia v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R117-48</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:24.312Z</lastUpdated>
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    <basicUdiDi>7350040638R117RJ</basicUdiDi>
    <tradeName>Devyser Thalassemia v2</tradeName>
    <deviceName>Devyser Thalassemia v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R117-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:23.120Z</lastUpdated>
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    <udiDi>07350040632178</udiDi>
    <basicUdiDi>7350040638R101R3</basicUdiDi>
    <tradeName>DEVYSER CFTR</tradeName>
    <deviceName>DEVYSER CFTR</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R101-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:14.722Z</lastUpdated>
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