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    <tradeName>MAGLUMI Fibrin/fibrinogen degradation products (CLIA) Controls</tradeName>
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    <tradeName>CL AIA-PACK DILUENT CONCENTRATE</tradeName>
    <deviceName>CL AIA-PACK DILUENT CONCENTRATE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
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    <deviceName>CL AIA-PACK SUBSTRATE SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <manufacturerName>2cureX A/S</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:09:44.836Z</lastUpdated>
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    <tradeName>CL AIA-PACK SUBSTRATE SET</tradeName>
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    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
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    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029702</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:53.477Z</lastUpdated>
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    <deviceName>Fecal Occult Blood Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:33:52.971Z</lastUpdated>
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    <deviceName>Serum Amyloid A Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-06-30T04:33:34.980Z</lastUpdated>
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    <deviceName>C-Reactive Protein Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
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    <lastUpdated>2026-06-30T04:33:33.759Z</lastUpdated>
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    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
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    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
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