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    <basicUdiDi>B-06974604720074</basicUdiDi>
    <tradeName>06974604720074</tradeName>
    <deviceName>Human MTHFR Gene Detection Kit(PCR-Fluorescence Method)</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-014-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:10.734Z</lastUpdated>
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    <udiDi>06974604720067</udiDi>
    <basicUdiDi>B-06974604720067</basicUdiDi>
    <tradeName>06974604720067</tradeName>
    <deviceName>Human ALDH2 Gene Detection Kit(PCR-Fluorescence Method)</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-012-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:09.931Z</lastUpdated>
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    <udiDi>06974604720050</udiDi>
    <basicUdiDi>B-06974604720050</basicUdiDi>
    <tradeName>06974604720050</tradeName>
    <deviceName>Human SLCO1B1and ApoE Gene Detection Kit(PCR-Fluorescence Method)</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-011-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:09.156Z</lastUpdated>
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    <udiDi>06974323012863</udiDi>
    <basicUdiDi>B-06974323012863</basicUdiDi>
    <tradeName>06974323012863</tradeName>
    <deviceName>Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:49.353Z</lastUpdated>
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    <udiDi>06974323012856</udiDi>
    <basicUdiDi>B-06974323012856</basicUdiDi>
    <tradeName>06974323012856</tradeName>
    <deviceName>Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:47.272Z</lastUpdated>
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    <udiDi>06974323012771</udiDi>
    <basicUdiDi>B-06974323012771</basicUdiDi>
    <tradeName>06974323012771</tradeName>
    <deviceName>Human ALDH2 Gene Polymorphism Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:34.164Z</lastUpdated>
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    <udiDi>06974323012764</udiDi>
    <basicUdiDi>B-06974323012764</basicUdiDi>
    <tradeName>06974323012764</tradeName>
    <deviceName>Human ALDH2 Gene Polymorphism Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:32.320Z</lastUpdated>
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    <udiDi>06971532201675</udiDi>
    <basicUdiDi>B-06971532201675</basicUdiDi>
    <tradeName>06971532201675</tradeName>
    <deviceName>Hearing Loss Susceptibility HRM Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-HLS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:55.136Z</lastUpdated>
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    <udiDi>06971532201651</udiDi>
    <basicUdiDi>B-06971532201651</basicUdiDi>
    <tradeName>06971532201651</tradeName>
    <deviceName>SOX1 and PAX1 Methylation Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-CCDNAm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:52.474Z</lastUpdated>
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    <udiDi>06971532201668</udiDi>
    <basicUdiDi>B-06971532201668</basicUdiDi>
    <tradeName>06971532201668</tradeName>
    <deviceName>Hearing Loss Susceptibility HRM Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-HLS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:50.477Z</lastUpdated>
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    <udiDi>06971532201576</udiDi>
    <basicUdiDi>B-06971532201576</basicUdiDi>
    <tradeName>06971532201576</tradeName>
    <deviceName>Hearing Loss Susceptibility GenoArray Diagnostic Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBGA-HLS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:49.769Z</lastUpdated>
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    <udiDi>06971532201644</udiDi>
    <basicUdiDi>B-06971532201644</basicUdiDi>
    <tradeName>06971532201644</tradeName>
    <deviceName>SOX1 and PAX1 Methylation Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-CCDNAm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:47.911Z</lastUpdated>
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    <udiDi>06971532201279</udiDi>
    <basicUdiDi>B-06971532201279</basicUdiDi>
    <tradeName>06971532201279</tradeName>
    <deviceName>APOE and SLCO1B1 Gene Polymorphism MCA Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-PGx/Statin</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:33.020Z</lastUpdated>
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    <udiDi>06971532201262</udiDi>
    <basicUdiDi>B-06971532201262</basicUdiDi>
    <tradeName>06971532201262</tradeName>
    <deviceName>APOE and SLCO1B1 Gene Polymorphism MCA Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-PGx/Statin</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:31.919Z</lastUpdated>
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    <udiDi>06971532201255</udiDi>
    <basicUdiDi>B-06971532201255</basicUdiDi>
    <tradeName>06971532201255</tradeName>
    <deviceName>CYP2C9 and VKORC1 Gene Polymorphism MCA Real-Time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-PGx/WFN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:30.263Z</lastUpdated>
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    <udiDi>06971532201248</udiDi>
    <basicUdiDi>B-06971532201248</basicUdiDi>
    <tradeName>06971532201248</tradeName>
    <deviceName>CYP2C9 and VKORC1 Gene Polymorphism MCA Real-Time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-PGx/WFN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:28.962Z</lastUpdated>
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    <udiDi>06971532201217</udiDi>
    <basicUdiDi>B-06971532201217</basicUdiDi>
    <tradeName>06971532201217</tradeName>
    <deviceName>MTHFR Gene Polymorphism MCA Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-PGx/FA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:24.893Z</lastUpdated>
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    <udiDi>06971532201200</udiDi>
    <basicUdiDi>B-06971532201200</basicUdiDi>
    <tradeName>06971532201200</tradeName>
    <deviceName>MTHFR Gene Polymorphism MCA Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-PGx/FA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:22.236Z</lastUpdated>
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    <udiDi>06971532200203</udiDi>
    <basicUdiDi>B-06971532200203</basicUdiDi>
    <tradeName>06971532200203</tradeName>
    <deviceName>Thalassemia GenoArray Diagnostic Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBGA-THAL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:15.847Z</lastUpdated>
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    <udiDi>04260152483762</udiDi>
    <basicUdiDi>B-04260152483762</basicUdiDi>
    <tradeName>RBC-FluoGene ABO basic</tradeName>
    <deviceName>RBC-FluoGene ABO basic</deviceName>
    <manufacturerName>inno-train Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024702</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001 086 040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:50:53.570Z</lastUpdated>
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