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    <basicUdiDi>B-06974238910438</basicUdiDi>
    <tradeName>Alpha-Fetoprotein (AFP) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAFP035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:58:34.118Z</lastUpdated>
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    <udiDi>06973914383146</udiDi>
    <basicUdiDi>B-06973914383146</basicUdiDi>
    <tradeName>06973914383146</tradeName>
    <deviceName>ALPHA-FetoProtein (AFP) Detection Kit (Magnetic Particle CLIA)</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.02.021C2.610</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:47:22.299Z</lastUpdated>
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    <udiDi>06973861684013</udiDi>
    <basicUdiDi>B-06973861684013</basicUdiDi>
    <tradeName>AFP Rapid Test Kit</tradeName>
    <deviceName>AFP Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02048002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:42:54.297Z</lastUpdated>
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    <udiDi>06973841001182</udiDi>
    <basicUdiDi>B-06973841001182</basicUdiDi>
    <tradeName>AFP Test Kit (FIA)</tradeName>
    <deviceName>AFP Test Kit (FIA)</deviceName>
    <manufacturerName>Guangdong Wesail Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0460</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:49.734Z</lastUpdated>
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    <udiDi>06973315739184</udiDi>
    <basicUdiDi>B-06973315739184</basicUdiDi>
    <tradeName>Alpha-Fetoprotein (AFP) Test Kit</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Test Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M4402CV</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:02:33.371Z</lastUpdated>
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    <udiDi>06972719604333</udiDi>
    <basicUdiDi>B-06972719604333</basicUdiDi>
    <tradeName>06972719604333</tradeName>
    <deviceName>Alpha-Fetoprotein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:46:18.139Z</lastUpdated>
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    <udiDi>06972719604326</udiDi>
    <basicUdiDi>B-06972719604326</basicUdiDi>
    <tradeName>06972719604326</tradeName>
    <deviceName>Alpha-Fetoprotein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:46:13.337Z</lastUpdated>
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    <udiDi>06972719602766</udiDi>
    <basicUdiDi>B-06972719602766</basicUdiDi>
    <tradeName>06972719602766</tradeName>
    <deviceName>Alpha-Fetoprotein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:40:54.233Z</lastUpdated>
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    <udiDi>06972719602742</udiDi>
    <basicUdiDi>B-06972719602742</basicUdiDi>
    <tradeName>06972719602742</tradeName>
    <deviceName>Alpha-Fetoprotein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:40:50.219Z</lastUpdated>
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    <udiDi>06972719602759</udiDi>
    <basicUdiDi>B-06972719602759</basicUdiDi>
    <tradeName>06972719602759</tradeName>
    <deviceName>Alpha-Fetoprotein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:40:49.432Z</lastUpdated>
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    <udiDi>06972719600663</udiDi>
    <basicUdiDi>B-06972719600663</basicUdiDi>
    <tradeName>06972719600663</tradeName>
    <deviceName>Alpha-Fetoprotein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215090009</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:32:55.191Z</lastUpdated>
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  <row>
    <udiDi>06971792054332</udiDi>
    <basicUdiDi>B-06971792054332</basicUdiDi>
    <tradeName>Alpha-fetoprotein (AFP) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KA001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:57:24.776Z</lastUpdated>
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  <row>
    <udiDi>06944904047898</udiDi>
    <basicUdiDi>69449040AB74000225E</basicUdiDi>
    <tradeName>Alpha-fetoprotein (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004241-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.983Z</lastUpdated>
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    <udiDi>06944904048246</udiDi>
    <basicUdiDi>69449040AB74000225E</basicUdiDi>
    <tradeName>AFP Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004283-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.621Z</lastUpdated>
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    <udiDi>03770024321340</udiDi>
    <basicUdiDi>B-03770024321340</basicUdiDi>
    <tradeName>RG-AFP</tradeName>
    <deviceName>OCFA07-AFP</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCFA07-AFP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:32:04.050Z</lastUpdated>
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    <udiDi>03770024321098</udiDi>
    <basicUdiDi>B-03770024321098</basicUdiDi>
    <tradeName>03770024321098</tradeName>
    <deviceName>ELSA2-AFP</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELSA2-AFP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:24.829Z</lastUpdated>
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    <udiDi>D-000012807185066R4</udiDi>
    <basicUdiDi>B-000012807185066R4</basicUdiDi>
    <tradeName>AFP Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>AFP Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:38.054Z</lastUpdated>
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    <udiDi>08806133044216</udiDi>
    <basicUdiDi>880613300123BL</basicUdiDi>
    <tradeName>ichroma™ AFP Neo</tradeName>
    <deviceName>ichroma™ AFP Neo</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-156</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:15.204Z</lastUpdated>
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    <udiDi>06939716404397</udiDi>
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    <tradeName>HOKAPI™ AFP</tradeName>
    <deviceName>HOKAPI™ AFP</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010102001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:31.788Z</lastUpdated>
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    <udiDi>06935740732789</udiDi>
    <basicUdiDi>69357407IIAS000016F7</basicUdiDi>
    <tradeName>06935740732789</tradeName>
    <deviceName>Alpha-fetoprotein （AFP）Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USIA00000168M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:19.385Z</lastUpdated>
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