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    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® Actin IgG ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708785</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:36.943Z</lastUpdated>
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    <udiDi>04250289504546</udiDi>
    <basicUdiDi>B-04250289504546</basicUdiDi>
    <tradeName>AESKUBLOTS® Liver Pro</tradeName>
    <deviceName>AESKUBLOTS® Liver Pro</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:15.391Z</lastUpdated>
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    <udiDi>08033891322625</udiDi>
    <basicUdiDi>803389132ALDSC00D3</basicUdiDi>
    <tradeName>CHORUS MACROARRAY LIVER DISEASES</tradeName>
    <deviceName>CHORUS MACROARRAY LIVER DISEASES</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:15:13.121Z</lastUpdated>
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    <udiDi>06950617403791</udiDi>
    <basicUdiDi>69506174IM441470E4</basicUdiDi>
    <tradeName>06950617403791</tradeName>
    <deviceName>Anti-LC-1 Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415470</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:57.465Z</lastUpdated>
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    <udiDi>06950617403784</udiDi>
    <basicUdiDi>69506174IM441470E4</basicUdiDi>
    <tradeName>06950617403784</tradeName>
    <deviceName>Anti-LC-1 Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414470</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:56.282Z</lastUpdated>
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    <udiDi>06950617403777</udiDi>
    <basicUdiDi>69506174IM441470E4</basicUdiDi>
    <tradeName>06950617403777</tradeName>
    <deviceName>Anti-LC-1 Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411470</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:50.260Z</lastUpdated>
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    <basicUdiDi>69506174IM441470E4</basicUdiDi>
    <tradeName>06950617403760</tradeName>
    <deviceName>Anti-LC-1 Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100701</emdnCode>
    <emdnDescription>HEPATITIS AUTOANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410470</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:49.470Z</lastUpdated>
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