<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975679490480</udiDi>
    <basicUdiDi>B-06975679490480</basicUdiDi>
    <tradeName>T4 (Total Thyroxine) Rapid Quantitative Test</tradeName>
    <deviceName>T4 (Total Thyroxine) Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:41:20.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225961</udiDi>
    <basicUdiDi>B-06975424225961</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>DL248201C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:11.599Z</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>06975132464218</udiDi>
    <basicUdiDi>B-06975132464218</basicUdiDi>
    <tradeName>06975132464218</tradeName>
    <deviceName>Total T4 Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTT4-302F-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:58.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070762797</udiDi>
    <basicUdiDi>B-06975070762797</basicUdiDi>
    <tradeName>Sharay TT4 (CLIA)</tradeName>
    <deviceName>Sharay TT4 (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>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18705001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:39:22.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068490275</udiDi>
    <basicUdiDi>B-06975068490275</basicUdiDi>
    <tradeName>Total Thyroxine（TT4）Rapid Quantitative Test（Fluorescence immunoassay）</tradeName>
    <deviceName>Total Thyroxine（TT4）Rapid Quantitative Test（Fluorescence immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP059.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:30:17.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986814453</udiDi>
    <basicUdiDi>B-06974986814453</basicUdiDi>
    <tradeName>Total Thyroxine (TT4) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Total Thyroxine (TT4) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:23:20.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813906</udiDi>
    <basicUdiDi>B-06974986813906</basicUdiDi>
    <tradeName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:25.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813890</udiDi>
    <basicUdiDi>B-06974986813890</basicUdiDi>
    <tradeName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>50 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:24.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813883</udiDi>
    <basicUdiDi>B-06974986813883</basicUdiDi>
    <tradeName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>25 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:24.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813876</udiDi>
    <basicUdiDi>B-06974986813876</basicUdiDi>
    <tradeName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Total thyroxine  Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>10 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:20.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813524</udiDi>
    <basicUdiDi>B-06974986813524</basicUdiDi>
    <tradeName>Total Thyroxine (TT4) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Total Thyroxine (TT4) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:20:24.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813517</udiDi>
    <basicUdiDi>B-06974986813517</basicUdiDi>
    <tradeName>Total Thyroxine (TT4) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Total Thyroxine (TT4) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</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>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:20:23.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974969982100</udiDi>
    <basicUdiDi>B-06974969982100</basicUdiDi>
    <tradeName>Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1003-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:13:14.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974969981530</udiDi>
    <basicUdiDi>B-06974969981530</basicUdiDi>
    <tradeName>Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1003-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:11:18.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974969980960</udiDi>
    <basicUdiDi>B-06974969980960</basicUdiDi>
    <tradeName>Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1003-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:09:21.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892923</udiDi>
    <basicUdiDi>B-06974674892923</basicUdiDi>
    <tradeName>Thyroxine ( T4 ) Detection Kit(CLIA)</tradeName>
    <deviceName>Thyroxine ( T4 ) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0164</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:17:32.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891568</udiDi>
    <basicUdiDi>B-06974674891568</basicUdiDi>
    <tradeName>Thyroxine (T4) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Thyroxine (T4) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:30.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671101813</udiDi>
    <basicUdiDi>B-06974671101813</basicUdiDi>
    <tradeName>06974671101813</tradeName>
    <deviceName>Total Thyroxine (TT4) Quantitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CK-A031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:02.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671101400</udiDi>
    <basicUdiDi>B-06974671101400</basicUdiDi>
    <tradeName>06974671101400</tradeName>
    <deviceName>Total Thyroxine (TT4) Quantitative Diagnostic Kit (TRFIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-TR-A003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:08:48.859Z</lastUpdated>
  </row>
</eudamedExport>