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    <deviceName>Automated Immunoassay System HISCL-800</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
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    <basicUdiDi>471989299Analyzer8A</basicUdiDi>
    <tradeName>Agnitio BioIC Analyzer</tradeName>
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    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <reference>BA-G2000 series</reference>
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    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
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    <tradeName>Access 2 Immunoassay System</tradeName>
    <deviceName>Access 2 Immunoassay System</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <lastUpdated>2026-07-30T17:35:32.607Z</lastUpdated>
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    <tradeName>Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90</tradeName>
    <deviceName>Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90</deviceName>
    <manufacturerName>Suzhou Astrabio Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041763</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8901000100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:00:10.826Z</lastUpdated>
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    <tradeName>SmarLumi</tradeName>
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    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>WP13</reference>
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    <lastUpdated>2026-07-23T03:48:21.150Z</lastUpdated>
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    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
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    <tradeName>SmarLumi</tradeName>
    <deviceName>Smarlumi™ Automatic Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:50.688Z</lastUpdated>
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    <tradeName>SmarLumi</tradeName>
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    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
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    <tradeName>Automatic Chemiluminescence Immunoassay Analyzer</tradeName>
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    <manufacturerName>Shanghai Medconn Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038658</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
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    <reference>NA</reference>
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    <lastUpdated>2026-07-22T09:28:57.050Z</lastUpdated>
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    <lastUpdated>2026-07-21T19:50:36.234Z</lastUpdated>
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    <manufacturerName>Dynex Technologies Inc</manufacturerName>
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    <lastUpdated>2026-07-19T15:28:37.723Z</lastUpdated>
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    <manufacturerName>Dynex Technologies Inc</manufacturerName>
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    <lastUpdated>2026-07-19T15:28:37.664Z</lastUpdated>
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