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    <basicUdiDi>B-06975491761140</basicUdiDi>
    <tradeName>06975491761140</tradeName>
    <deviceName>Antinuclear Antibodies Spectrum Test Kit (Microarray Chip)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-12 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:54.781Z</lastUpdated>
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    <udiDi>06975491761133</udiDi>
    <basicUdiDi>B-06975491761133</basicUdiDi>
    <tradeName>06975491761133</tradeName>
    <deviceName>Antinuclear Antibodies Spectrum Test Kit (Microarray Chip)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T-5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:37.931Z</lastUpdated>
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    <udiDi>06975491761126</udiDi>
    <basicUdiDi>B-06975491761126</basicUdiDi>
    <tradeName>06975491761126</tradeName>
    <deviceName>Antinuclear Antibodies Spectrum Test Kit (Microarray Chip)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T-12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:35.527Z</lastUpdated>
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    <udiDi>06975491761119</udiDi>
    <basicUdiDi>B-06975491761119</basicUdiDi>
    <tradeName>06975491761119</tradeName>
    <deviceName>Infertility Multiplex Auto-antibodies test kit ( Microarray Chip )</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:33.127Z</lastUpdated>
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    <udiDi>06975424226760</udiDi>
    <basicUdiDi>B-06975424226760</basicUdiDi>
    <tradeName>Anti-PLA2R CLIA Assay Kit</tradeName>
    <deviceName>Anti-PLA2R CLIA Assay Kit</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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20282EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:10.820Z</lastUpdated>
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    <udiDi>06975424226753</udiDi>
    <basicUdiDi>B-06975424226753</basicUdiDi>
    <tradeName>Anti-GBM CLIA Assay Kit</tradeName>
    <deviceName>Anti-GBM CLIA Assay Kit</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>CL20122EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:10.019Z</lastUpdated>
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    <udiDi>06975424226746</udiDi>
    <basicUdiDi>B-06975424226746</basicUdiDi>
    <tradeName>Anti-PR3 CLIA Assay Kit</tradeName>
    <deviceName>Anti-PR3 CLIA Assay Kit</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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20102EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:09.233Z</lastUpdated>
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  <row>
    <udiDi>06975424226739</udiDi>
    <basicUdiDi>B-06975424226739</basicUdiDi>
    <tradeName>Anti-Myeloperoxidase CLIA Assay Kit</tradeName>
    <deviceName>Anti-Myeloperoxidase CLIA Assay Kit</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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20112EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:05.234Z</lastUpdated>
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  <row>
    <udiDi>06975424226616</udiDi>
    <basicUdiDi>B-06975424226616</basicUdiDi>
    <tradeName>GADA CLIA Assay Kit</tradeName>
    <deviceName>GADA CLIA Assay Kit</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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20152EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:45.208Z</lastUpdated>
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  <row>
    <udiDi>06975424225800</udiDi>
    <basicUdiDi>B-06975424225800</basicUdiDi>
    <tradeName>IA-2A Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>IA-2A 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246601C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:44:02.206Z</lastUpdated>
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  <row>
    <udiDi>06975424225794</udiDi>
    <basicUdiDi>B-06975424225794</basicUdiDi>
    <tradeName>GADA Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>GADA 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246501C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:44:01.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225787</udiDi>
    <basicUdiDi>B-06975424225787</basicUdiDi>
    <tradeName>AMA-M2 Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>AMA-M2 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246401C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:55.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225770</udiDi>
    <basicUdiDi>B-06975424225770</basicUdiDi>
    <tradeName>PLA2R IgG Antibody Assay kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>PLA2R IgG Antibody 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246301C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:55.112Z</lastUpdated>
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  <row>
    <udiDi>06975424225527</udiDi>
    <basicUdiDi>B-06975424225527</basicUdiDi>
    <tradeName>Anti-GBM Assay Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-GBM 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>W0102109014</emdnCode>
    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL213201C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:04.526Z</lastUpdated>
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  <row>
    <udiDi>06975424225060</udiDi>
    <basicUdiDi>B-06975424225060</basicUdiDi>
    <tradeName>06975424225060</tradeName>
    <deviceName>IA-2A 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:19.653Z</lastUpdated>
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    <udiDi>06975424225053</udiDi>
    <basicUdiDi>B-06975424225053</basicUdiDi>
    <tradeName>06975424225053</tradeName>
    <deviceName>GADA 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246506</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:18.843Z</lastUpdated>
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  <row>
    <udiDi>06975424225046</udiDi>
    <basicUdiDi>B-06975424225046</basicUdiDi>
    <tradeName>06975424225046</tradeName>
    <deviceName>AMA-M2 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246406</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:14.842Z</lastUpdated>
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  <row>
    <udiDi>06975424225039</udiDi>
    <basicUdiDi>B-06975424225039</basicUdiDi>
    <tradeName>06975424225039</tradeName>
    <deviceName>PLA2R IgG Antibody 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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:14.034Z</lastUpdated>
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    <udiDi>06975424224230</udiDi>
    <basicUdiDi>B-06975424224230</basicUdiDi>
    <tradeName>Anti-PLA2R CLIA Assay Kit</tradeName>
    <deviceName>Anti-PLA2R CLIA Assay Kit</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>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30282EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:33.891Z</lastUpdated>
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  <row>
    <udiDi>06975424224223</udiDi>
    <basicUdiDi>B-06975424224223</basicUdiDi>
    <tradeName>Anti-GBM CLIA Assay Kit</tradeName>
    <deviceName>Anti-GBM CLIA Assay Kit</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>CL30122EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:29.891Z</lastUpdated>
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