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    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <tradeName>α-fetoprotein test (Up-converting Phosphor Technology)</tradeName>
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    <manufacturerName>Beijing Hotgen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015566</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <tradeName>AFP CLIA Microparticles</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <reference>CMB0103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <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>105-004214-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:53:44.519Z</lastUpdated>
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    <tradeName>iFlash-AFP</tradeName>
    <deviceName>iFlash-AFP</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-60601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:42.714Z</lastUpdated>
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    <udiDi>04260157631946</udiDi>
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    <tradeName>B·R·A·H·M·S AFP KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S AFP KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>816075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:01.664Z</lastUpdated>
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    <tradeName>VIDAS® AFP</tradeName>
    <deviceName>VIDAS® AFP</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30413</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:41.861Z</lastUpdated>
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    <tradeName>Access AFP (100 &amp; 200 Test)(Reagent Pack)</tradeName>
    <deviceName>Access AFP (100 &amp; 200 Test)(Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:35:03.796Z</lastUpdated>
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    <deviceName>Access AFP (300 &amp; 600 Test Kit)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <lastUpdated>2026-07-30T17:35:02.993Z</lastUpdated>
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    <tradeName>Access AFP Sample Diluent</tradeName>
    <deviceName>Access AFP Sample Diluent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <lastUpdated>2026-07-30T17:34:57.380Z</lastUpdated>
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    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <reference>314471</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:36.302Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
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    <lastUpdated>2026-07-20T19:49:35.628Z</lastUpdated>
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    <tradeName>AFP Rapid Test Device</tradeName>
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    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <tradeName>ADVIA Centaur® AFP</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <lastUpdated>2026-07-15T21:32:49.142Z</lastUpdated>
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    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
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    <lastUpdated>2026-07-15T07:56:58.629Z</lastUpdated>
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    <tradeName>AFP Assay Kit (ECLIA)</tradeName>
    <deviceName>AFP Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K001</reference>
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    <lastUpdated>2026-07-15T03:12:30.468Z</lastUpdated>
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