<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975424225084</udiDi>
    <basicUdiDi>B-06975424225084</basicUdiDi>
    <tradeName>06975424225084</tradeName>
    <deviceName>Anti-MCV 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:21.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225077</udiDi>
    <basicUdiDi>B-06975424225077</basicUdiDi>
    <tradeName>06975424225077</tradeName>
    <deviceName>Helicobacter Pylori Antigen Test（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>W0105010499</emdnCode>
    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:20.442Z</lastUpdated>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <udiDi>06975424225022</udiDi>
    <basicUdiDi>B-06975424225022</basicUdiDi>
    <tradeName>06975424225022</tradeName>
    <deviceName>Anti-tissue transglutaminase Antibody IgA/IgG  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>W0102100601</emdnCode>
    <emdnDescription>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:13.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225015</udiDi>
    <basicUdiDi>B-06975424225015</basicUdiDi>
    <tradeName>Cystatin C Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Cystatin-C  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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:12.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225008</udiDi>
    <basicUdiDi>B-06975424225008</basicUdiDi>
    <tradeName>Calprotectin Assay kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Calprotectin 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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL245603</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:08.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224377</udiDi>
    <basicUdiDi>B-06975424224377</basicUdiDi>
    <tradeName>IgG4 CLIA Assay Kit</tradeName>
    <deviceName>IgG4 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30762EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:07.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224360</udiDi>
    <basicUdiDi>B-06975424224360</basicUdiDi>
    <tradeName>Free T4 CLIA Assay Kit</tradeName>
    <deviceName>Free T4 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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31062EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:06.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224353</udiDi>
    <basicUdiDi>B-06975424224353</basicUdiDi>
    <tradeName>Free T3 CLIA Assay Kit</tradeName>
    <deviceName>Free T3 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>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31052EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:06.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224346</udiDi>
    <basicUdiDi>B-06975424224346</basicUdiDi>
    <tradeName>TSH CLIA Assay Kit</tradeName>
    <deviceName>TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31012EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:02.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224339</udiDi>
    <basicUdiDi>B-06975424224339</basicUdiDi>
    <tradeName>T4 CLIA Assay Kit</tradeName>
    <deviceName>T4 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>W01020406</emdnCode>
    <emdnDescription>T- UPTAKE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31042EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:01.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224322</udiDi>
    <basicUdiDi>B-06975424224322</basicUdiDi>
    <tradeName>T3 CLIA Assay Kit</tradeName>
    <deviceName>T3 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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31032EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:00.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224315</udiDi>
    <basicUdiDi>B-06975424224315</basicUdiDi>
    <tradeName>PTH CLIA Assay Kit</tradeName>
    <deviceName>PTH 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30792EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:59.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224285</udiDi>
    <basicUdiDi>B-06975424224285</basicUdiDi>
    <tradeName>TRAb CLIA Assay Kit</tradeName>
    <deviceName>TRAb 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30742EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:55.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224278</udiDi>
    <basicUdiDi>B-06975424224278</basicUdiDi>
    <tradeName>Thyroglobulin CLIA Assay Kit</tradeName>
    <deviceName>Thyroglobulin 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>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31252EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:54.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224308</udiDi>
    <basicUdiDi>B-06975424224308</basicUdiDi>
    <tradeName>TPOAb CLIA Assay Kit</tradeName>
    <deviceName>TPOAb 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30752EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:54.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224292</udiDi>
    <basicUdiDi>B-06975424224292</basicUdiDi>
    <tradeName>TGAb CLIA Assay Kit</tradeName>
    <deviceName>TGAb 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30802EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:53.351Z</lastUpdated>
  </row>
</eudamedExport>