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    <tradeName>EliA GBM Well</tradeName>
    <deviceName>EliA GBM</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-5514-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:13.693Z</lastUpdated>
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    <udiDi>06950617403678</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
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    <deviceName>Anti-GBM 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>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:28.656Z</lastUpdated>
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    <udiDi>06950617403661</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
    <tradeName>06950617403661</tradeName>
    <deviceName>Anti-GBM 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>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:27.447Z</lastUpdated>
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    <udiDi>06950617403654</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
    <tradeName>06950617403654</tradeName>
    <deviceName>Anti-GBM 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>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:21.436Z</lastUpdated>
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    <udiDi>06950617403647</udiDi>
    <basicUdiDi>69506174IM441460DZ</basicUdiDi>
    <tradeName>06950617403647</tradeName>
    <deviceName>Anti-GBM 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>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410460</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:42:20.529Z</lastUpdated>
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    <udiDi>06942359513340</udiDi>
    <basicUdiDi>697015090000315HC</basicUdiDi>
    <tradeName>Anti-GBM IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1710</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:51:09.689Z</lastUpdated>
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    <udiDi>06942359513326</udiDi>
    <basicUdiDi>697015090000315HC</basicUdiDi>
    <tradeName>Anti-GBM IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1708</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:51:06.086Z</lastUpdated>
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    <udiDi>06975424222755</udiDi>
    <basicUdiDi>B-06975424222755</basicUdiDi>
    <tradeName>Anti-GBM CLIA Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30122E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:32:34.644Z</lastUpdated>
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