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    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1152</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:04.526Z</lastUpdated>
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    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T12:38:03.717Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
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    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
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    <lastUpdated>2026-07-02T12:38:02.926Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:58.918Z</lastUpdated>
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    <udiDi>06974183540834</udiDi>
    <basicUdiDi>697418354A08NV</basicUdiDi>
    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A08</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:58.110Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:57.323Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:56.522Z</lastUpdated>
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