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    <tradeName>08012992500545</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:43:32.163Z</lastUpdated>
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    <udiDi>08012992500538</udiDi>
    <basicUdiDi>B-08012992500538</basicUdiDi>
    <tradeName>08012992500538</tradeName>
    <deviceName>ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
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    <udiDi>06975424225633</udiDi>
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    <tradeName>Anti-PR3 Assay Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-PR3 Assay Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
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    <tradeName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
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    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234501C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <udiDi>06975424223936</udiDi>
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    <tradeName>06975424223936</tradeName>
    <deviceName>Anti-PR3 Assay Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234606</reference>
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    <lastUpdated>2026-07-06T19:40:31.408Z</lastUpdated>
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    <udiDi>06975424223929</udiDi>
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    <tradeName>06975424223929</tradeName>
    <deviceName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:30.608Z</lastUpdated>
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    <udiDi>06975424221857</udiDi>
    <basicUdiDi>B-06975424221857</basicUdiDi>
    <tradeName>Anti-PR3 Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-PR3 Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:37:05.552Z</lastUpdated>
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    <udiDi>06975424221840</udiDi>
    <basicUdiDi>B-06975424221840</basicUdiDi>
    <tradeName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-MPO Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:37:04.772Z</lastUpdated>
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    <udiDi>06975070769314</udiDi>
    <basicUdiDi>B-06975070769314</basicUdiDi>
    <tradeName>Sharay Anti-MPO IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-MPO IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000722</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:50:27.823Z</lastUpdated>
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    <udiDi>06975070769307</udiDi>
    <basicUdiDi>B-06975070769307</basicUdiDi>
    <tradeName>Sharay Anti-PR3 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-PR3 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000878</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:50:25.443Z</lastUpdated>
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    <udiDi>06975070761035</udiDi>
    <basicUdiDi>B-06975070761035</basicUdiDi>
    <tradeName>Sharay Anti-PR3 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-PR3 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18102001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:33:19.083Z</lastUpdated>
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    <udiDi>06975070761011</udiDi>
    <basicUdiDi>B-06975070761011</basicUdiDi>
    <tradeName>Sharay Anti-MPO IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-MPO IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18103001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:33:15.080Z</lastUpdated>
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    <udiDi>04250289504775</udiDi>
    <basicUdiDi>B-04250289504775</basicUdiDi>
    <tradeName>AESKUSLIDES® ANCA Formalin</tradeName>
    <deviceName>AESKUSLIDES® ANCA</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>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54.051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:21.239Z</lastUpdated>
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    <udiDi>04250289504751</udiDi>
    <basicUdiDi>B-04250289504751</basicUdiDi>
    <tradeName>AESKUSLIDES® ANCA Ethanol</tradeName>
    <deviceName>AESKUSLIDES® ANCA</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>W0102100401</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>54.050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:20.453Z</lastUpdated>
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    <udiDi>04250289504522</udiDi>
    <basicUdiDi>B-04250289504522</basicUdiDi>
    <tradeName>AESKUBLOTS® Vasculitis Pro</tradeName>
    <deviceName>AESKUBLOTS® Vasculitis Pro</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:08.432Z</lastUpdated>
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    <udiDi>04250289503839</udiDi>
    <basicUdiDi>B-04250289503839</basicUdiDi>
    <tradeName>AESKUSLIDES® ANCA Formalin</tradeName>
    <deviceName>AESKUSLIDES® ANCA</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>54.101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:06.045Z</lastUpdated>
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    <udiDi>04250289503822</udiDi>
    <basicUdiDi>B-04250289503822</basicUdiDi>
    <tradeName>AESKUSLIDES® ANCA Ethanol</tradeName>
    <deviceName>AESKUSLIDES® ANCA</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>W0102100401</emdnCode>
    <emdnDescription>ANCA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54.100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:02.030Z</lastUpdated>
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    <udiDi>04049325014343</udiDi>
    <basicUdiDi>B-04049325014343</basicUdiDi>
    <tradeName>PR3 IgG (c-ANCA) capture ELISA</tradeName>
    <deviceName>PR3 IgG (c-ANCA) capture ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30112111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:22.294Z</lastUpdated>
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    <udiDi>03532672001384</udiDi>
    <basicUdiDi>B-03532672001384</basicUdiDi>
    <tradeName>FIDIS Vasculitis</tradeName>
    <deviceName>FIDIS Vasculitis</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MX 007</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:42:20.643Z</lastUpdated>
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    <udiDi>D-0320517904XF</udiDi>
    <basicUdiDi>B-0320517904XF</basicUdiDi>
    <tradeName>PR3 IgG (eCLIA)</tradeName>
    <deviceName>PR3 IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517904</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:17.080Z</lastUpdated>
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