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    <basicUdiDi>B-06976457970934</basicUdiDi>
    <tradeName>EUYI β-Globin Gene Variation Test (PCR-RDB)</tradeName>
    <deviceName>EUYI β-Globin Gene Variation Test (PCR-RDB)</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100THV-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:21.783Z</lastUpdated>
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    <udiDi>06976457970057</udiDi>
    <basicUdiDi>B-06976457970057</basicUdiDi>
    <tradeName>EUYI β-Globin Gene Variation Test</tradeName>
    <deviceName>EUYI β-Globin Gene Variation Test</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100THB-24</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:20.169Z</lastUpdated>
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    <udiDi>06976457970033</udiDi>
    <basicUdiDi>B-06976457970033</basicUdiDi>
    <tradeName>EUYI α-Thalassemia Genotyping Kit (Nondeletion)</tradeName>
    <deviceName>EUYI α-Thalassemia Genotyping Kit (Nondeletion)</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100THS-24</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:15.377Z</lastUpdated>
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    <udiDi>06976457970002</udiDi>
    <basicUdiDi>B-06976457970002</basicUdiDi>
    <tradeName>EUYI α-Thalassemia Test (Gap-PCR)</tradeName>
    <deviceName>EUYI α-Thalassemia Test (Gap-PCR)</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100THA-24</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:08.988Z</lastUpdated>
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    <udiDi>06975358886115</udiDi>
    <basicUdiDi>B-06975358886115</basicUdiDi>
    <tradeName>PCR-CE α/β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α/β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:01.062Z</lastUpdated>
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    <udiDi>06975358886108</udiDi>
    <basicUdiDi>B-06975358886108</basicUdiDi>
    <tradeName>PCR-CE α/β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α/β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:00.245Z</lastUpdated>
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    <udiDi>06975358886016</udiDi>
    <basicUdiDi>B-06975358886016</basicUdiDi>
    <tradeName>PCR-CE β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:59.454Z</lastUpdated>
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    <udiDi>06975358886009</udiDi>
    <basicUdiDi>B-06975358886009</basicUdiDi>
    <tradeName>PCR-CE β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:55.606Z</lastUpdated>
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  <row>
    <udiDi>06975358885910</udiDi>
    <basicUdiDi>B-06975358885910</basicUdiDi>
    <tradeName>PCR-CE α-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:54.644Z</lastUpdated>
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    <udiDi>06975358885903</udiDi>
    <basicUdiDi>B-06975358885903</basicUdiDi>
    <tradeName>PCR-CE α-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:54.311Z</lastUpdated>
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    <udiDi>06975358885811</udiDi>
    <basicUdiDi>B-06975358885811</basicUdiDi>
    <tradeName>PCR-CE NOTCH2NLC Kit</tradeName>
    <deviceName>PCR-CE NOTCH2NLC Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:53.039Z</lastUpdated>
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  <row>
    <udiDi>06975358885804</udiDi>
    <basicUdiDi>B-06975358885804</basicUdiDi>
    <tradeName>PCR-CE NOTCH2NLC Kit</tradeName>
    <deviceName>PCR-CE NOTCH2NLC Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:49.034Z</lastUpdated>
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    <udiDi>06975358885217</udiDi>
    <basicUdiDi>B-06975358885217</basicUdiDi>
    <tradeName>06975358885217</tradeName>
    <deviceName>PCR-CE DMD gene Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010102</emdnCode>
    <emdnDescription>DUCHENNE MUSCULAR DYSTROPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:36.227Z</lastUpdated>
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    <udiDi>06975358885200</udiDi>
    <basicUdiDi>B-06975358885200</basicUdiDi>
    <tradeName>06975358885200</tradeName>
    <deviceName>PCR-CE DMD gene Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010102</emdnCode>
    <emdnDescription>DUCHENNE MUSCULAR DYSTROPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110005</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:35.425Z</lastUpdated>
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    <udiDi>06975358885118</udiDi>
    <basicUdiDi>B-06975358885118</basicUdiDi>
    <tradeName>06975358885118</tradeName>
    <deviceName>PCR-CE SMN1/2  Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110004</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:34.630Z</lastUpdated>
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    <udiDi>06975358885101</udiDi>
    <basicUdiDi>B-06975358885101</basicUdiDi>
    <tradeName>06975358885101</tradeName>
    <deviceName>PCR-CE SMN1/2  Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110003</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:33.822Z</lastUpdated>
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    <udiDi>06975358885019</udiDi>
    <basicUdiDi>B-06975358885019</basicUdiDi>
    <tradeName>06975358885019</tradeName>
    <deviceName>PCR-CE FMR1 Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:28.228Z</lastUpdated>
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    <udiDi>06975358885002</udiDi>
    <basicUdiDi>B-06975358885002</basicUdiDi>
    <tradeName>06975358885002</tradeName>
    <deviceName>PCR-CE FMR1 Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:27.421Z</lastUpdated>
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    <udiDi>06974968584022</udiDi>
    <basicUdiDi>B-06974968584022</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>Cystic Fibrosis Detection Kit Based On Whole Exome Sequencing Technology (Sequencing Method)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000154</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:08.221Z</lastUpdated>
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    <udiDi>06974968583841</udiDi>
    <basicUdiDi>B-06974968583841</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>Hereditary Deafness Gene Detection Kit (Sequencing Method)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000111</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:07.413Z</lastUpdated>
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