<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975424223592</udiDi>
    <basicUdiDi>B-06975424223592</basicUdiDi>
    <tradeName>06975424223592</tradeName>
    <deviceName>Procalcitonin 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>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL190207</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:34.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223585</udiDi>
    <basicUdiDi>B-06975424223585</basicUdiDi>
    <tradeName>06975424223585</tradeName>
    <deviceName>C- reactive protein 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL190107</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:33.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223554</udiDi>
    <basicUdiDi>B-06975424223554</basicUdiDi>
    <tradeName>FT4 Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>FT4 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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL249001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:32.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223547</udiDi>
    <basicUdiDi>B-06975424223547</basicUdiDi>
    <tradeName>FT3 Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>FT3 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>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248901</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:32.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223530</udiDi>
    <basicUdiDi>B-06975424223530</basicUdiDi>
    <tradeName>CEA Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>CEA 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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:28.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223523</udiDi>
    <basicUdiDi>B-06975424223523</basicUdiDi>
    <tradeName>AFP Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>AFP 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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248701</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:27.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223516</udiDi>
    <basicUdiDi>B-06975424223516</basicUdiDi>
    <tradeName>PSA Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>PSA 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>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248601</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:26.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223479</udiDi>
    <basicUdiDi>B-06975424223479</basicUdiDi>
    <tradeName>T4 Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>T4 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>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:25.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223462</udiDi>
    <basicUdiDi>B-06975424223462</basicUdiDi>
    <tradeName>T3 Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>T3 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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:21.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223455</udiDi>
    <basicUdiDi>B-06975424223455</basicUdiDi>
    <tradeName>β- HCG Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>β- HCG 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>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:20.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223448</udiDi>
    <basicUdiDi>B-06975424223448</basicUdiDi>
    <tradeName>Testosterone Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>Testosterone 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>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247901</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:20.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223431</udiDi>
    <basicUdiDi>B-06975424223431</basicUdiDi>
    <tradeName>Progesterone Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>Progesterone 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>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:19.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223424</udiDi>
    <basicUdiDi>B-06975424223424</basicUdiDi>
    <tradeName>FSH Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>FSH 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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247701</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:15.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223417</udiDi>
    <basicUdiDi>B-06975424223417</basicUdiDi>
    <tradeName>LH Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>LH 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>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247601</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:14.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223400</udiDi>
    <basicUdiDi>B-06975424223400</basicUdiDi>
    <tradeName>AMH Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>AMH 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>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMH Assay Kit  (Fluorescence Immunoassay)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:13.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223387</udiDi>
    <basicUdiDi>B-06975424223387</basicUdiDi>
    <tradeName>CA19-9 Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>CA19-9 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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:12.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223370</udiDi>
    <basicUdiDi>B-06975424223370</basicUdiDi>
    <tradeName>Prolactin Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>Prolactin 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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246901</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:08.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223363</udiDi>
    <basicUdiDi>B-06975424223363</basicUdiDi>
    <tradeName>TSH Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:08.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223356</udiDi>
    <basicUdiDi>B-06975424223356</basicUdiDi>
    <tradeName>Cortisol Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>Cortisol 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>W0102050115</emdnCode>
    <emdnDescription>CORTICOSTERON (R/M)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL245801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:07.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223349</udiDi>
    <basicUdiDi>B-06975424223349</basicUdiDi>
    <tradeName>Anti-tissue transglutaminase Antibody IgA/IgG  Assay Kit (Fluorescence Immunoassay)</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>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:06.446Z</lastUpdated>
  </row>
</eudamedExport>