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    <tradeName>EliA Cardiolipin IgA Well</tradeName>
    <deviceName>EliA Cardiolipin IgA</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-03T01:16:22.494Z</lastUpdated>
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    <tradeName>Anti-β2-GP1 IgA CLIA Microparticles</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <tradeName>Anti-β2-GP1 CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
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    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2908</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:51:35.289Z</lastUpdated>
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    <tradeName>Anti-beta 2 Glycoprotein 1 Antibody IgA/G/M (β2-GP1-IgA/G/M) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-beta 2 Glycoprotein 1 Antibody IgA/G/M (β2-GP1-IgA/G/M) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB2001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:33.684Z</lastUpdated>
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    <tradeName>Anti-cardiolipin antibody IgA/G/M (aCL-A/G/M) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-cardiolipin antibody IgA/G/M (aCL-A/G/M) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB1601</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:26.499Z</lastUpdated>
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    <tradeName>Cardiolipin/ ß2-GPI IgG Dot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ANTI-PHOSPHOLIP SYNDROME - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD CBGD</reference>
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    <lastUpdated>2026-06-25T14:23:50.474Z</lastUpdated>
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    <tradeName>Cardiolipin/β2- GPI IgG for BDI</tradeName>
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    <tradeName>DIASpot Neptune APS IgG</tradeName>
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    <manufacturerName>D-tek s.a.</manufacturerName>
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    <tradeName>Anti-aPS/PT IgM CLIA Assay Kit</tradeName>
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    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <reference>CL30292E</reference>
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    <tradeName>Anti-aPS/PT IgG  CLIA Assay Kit</tradeName>
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    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <tradeName>Anti-β2-Glycoprotein I IgM CLIA Assay Kit</tradeName>
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    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <tradeName>Anti-β2-Glycoprotein I IgA CLIA Assay Kit</tradeName>
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    <reference>CL30062E</reference>
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    <tradeName>Anti-β2-Glycoprotein I IgG CLIA Assay Kit</tradeName>
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    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
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    <reference>CL30052E</reference>
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    <tradeName>Anti-Cardiolipin IgM CLIA Assay Kit</tradeName>
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    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30032E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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