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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <tradeName>AESKULISA® Scl-70</tradeName>
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    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-20T15:37:54.654Z</lastUpdated>
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    <basicUdiDi>B-06975424226579</basicUdiDi>
    <tradeName>Anti-Scl-70 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Scl-70 Antibody CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
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    <reference>CL20402EN</reference>
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    <lastUpdated>2026-07-16T16:26:05.933Z</lastUpdated>
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    <udiDi>D-IM4422259JX</udiDi>
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    <tradeName>D-IM4422259JX</tradeName>
    <deviceName>Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>Scl-70</tradeName>
    <deviceName>Scl-70</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <reference>N712A24SCL</reference>
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    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Scl-70 Reagents</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>
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    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701328</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:22:06.986Z</lastUpdated>
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    <tradeName>Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)</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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234401C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:18.132Z</lastUpdated>
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    <udiDi>06975424224049</udiDi>
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    <tradeName>Anti-Scl-70 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Scl-70 Antibody CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
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    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30402EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:02.677Z</lastUpdated>
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    <deviceName>Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
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    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234406</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:29.803Z</lastUpdated>
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    <tradeName>Anti-Scl-70 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Scl-70 Antibody CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:37:17.545Z</lastUpdated>
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    <tradeName>Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
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    <lastUpdated>2026-07-06T19:37:11.142Z</lastUpdated>
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    <tradeName>Sharay Anti-Scl-70 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Scl-70 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-06T18:50:55.098Z</lastUpdated>
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    <tradeName>Sharay Anti-Scl-70 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Scl-70 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Scl-70-Ab ELISA</tradeName>
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    <manufacturerName>IBL International GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE75251</reference>
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    <lastUpdated>2026-07-06T00:09:51.000Z</lastUpdated>
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    <deviceName>Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit</deviceName>
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    <deviceName>Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit</deviceName>
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    <lastUpdated>2026-06-28T05:44:55.149Z</lastUpdated>
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