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    <deviceName>SALSA MLPA Probemix P018 SHOX</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>P018-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:43:02.225Z</lastUpdated>
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    <udiDi>08720211480355</udiDi>
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    <tradeName>SALSA MLPA Probemix P018 SHOX</tradeName>
    <deviceName>SALSA MLPA Probemix P018 SHOX</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
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    <basicUdiDi>872021148P0185P</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P018 SHOX</tradeName>
    <deviceName>SALSA MLPA Probemix P018 SHOX</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <deviceName>SALSA MLPA Probemix P017 MEN1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P017-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:53.806Z</lastUpdated>
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    <udiDi>08720211480324</udiDi>
    <basicUdiDi>872021148P0175M</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P017 MEN1</tradeName>
    <deviceName>SALSA MLPA Probemix P017 MEN1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
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    <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>P017-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:52.626Z</lastUpdated>
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    <udiDi>08720211480256</udiDi>
    <basicUdiDi>872021148P0155H</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P015 MECP2</tradeName>
    <deviceName>SALSA MLPA Probemix P015 MECP2</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>P015-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:50.210Z</lastUpdated>
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    <udiDi>08720211480249</udiDi>
    <basicUdiDi>872021148P0085L</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P008 PMS2</tradeName>
    <deviceName>SALSA MLPA Probemix P008 PMS2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
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    <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>P008-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:44.204Z</lastUpdated>
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    <udiDi>08720211480232</udiDi>
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    <tradeName>SALSA MLPA Probemix P008 PMS2</tradeName>
    <deviceName>SALSA MLPA Probemix P008 PMS2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:43.001Z</lastUpdated>
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    <udiDi>08720211480225</udiDi>
    <basicUdiDi>872021148P0085L</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P008 PMS2</tradeName>
    <deviceName>SALSA MLPA Probemix P008 PMS2</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>P008-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:41.800Z</lastUpdated>
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    <udiDi>08720211480041</udiDi>
    <basicUdiDi>872021148P00258</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P002 BRCA1</tradeName>
    <deviceName>SALSA MLPA Probemix P002 BRCA1</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>P002-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:40.601Z</lastUpdated>
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    <udiDi>08720211480034</udiDi>
    <basicUdiDi>872021148P00258</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P002 BRCA1</tradeName>
    <deviceName>SALSA MLPA Probemix P002 BRCA1</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>P002-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:34.597Z</lastUpdated>
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    <udiDi>08720211480010</udiDi>
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    <tradeName>SALSA MLPA Probemix P002 BRCA1</tradeName>
    <deviceName>SALSA MLPA Probemix P002 BRCA1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P002-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:33.417Z</lastUpdated>
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    <udiDi>08437016942840</udiDi>
    <basicUdiDi>8437016942GVS-MTH-MRE</basicUdiDi>
    <tradeName>Genvinset® MTHFR multiplex 96 test</tradeName>
    <deviceName>Genvinset® MTHFR 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-MTH-M-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:33.100Z</lastUpdated>
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    <basicUdiDi>8437016942GVS-MTH-MRE</basicUdiDi>
    <tradeName>Genvinset® MTHFR multiplex 48 test</tradeName>
    <deviceName>Genvinset® MTHFR multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-MTH-M-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:26.840Z</lastUpdated>
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    <basicUdiDi>8437016942GVS-MTH-MRE</basicUdiDi>
    <tradeName>Genvinset® MTHFR multiplex 24 test</tradeName>
    <deviceName>Genvinset® MTHFR multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-MTH-M-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:25.643Z</lastUpdated>
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    <basicUdiDi>8437016942GVS-HFEM3T</basicUdiDi>
    <tradeName>Genvinset® HFE multiplex 96 test</tradeName>
    <deviceName>Genvinset® HFE multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-HFE-M-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:24.450Z</lastUpdated>
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    <basicUdiDi>8437016942GVS-HFEM3T</basicUdiDi>
    <tradeName>Genvinset® HFE multiplex 48 test</tradeName>
    <deviceName>Genvinset® HFE multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-HFE-M-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:23.245Z</lastUpdated>
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    <tradeName>Genvinset® HFE multiplex 24 test</tradeName>
    <deviceName>Genvinset® HFE multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-HFE-M-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:17.242Z</lastUpdated>
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    <tradeName>Genvinset® HFE S65C 96 test</tradeName>
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    <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>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-S65C-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:07.636Z</lastUpdated>
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    <tradeName>Genvinset® Factor II G20210A 96 test</tradeName>
    <deviceName>Genvinset® Factor II G20210A</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>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FII-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:06.431Z</lastUpdated>
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