<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76189GA</udiDi>
    <basicUdiDi>B-DC76189GA</basicUdiDi>
    <tradeName>iStar-T4</tradeName>
    <deviceName>iStar-T4</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76189</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:07:10.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76190FT</udiDi>
    <basicUdiDi>B-DC76190FT</basicUdiDi>
    <tradeName>iStar-FT4</tradeName>
    <deviceName>iStar-FT4</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76190</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:07:09.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76187G6</udiDi>
    <basicUdiDi>B-DC76187G6</basicUdiDi>
    <tradeName>iStar-T4</tradeName>
    <deviceName>iStar-T4</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76188</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:07:08.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76188G8</udiDi>
    <basicUdiDi>B-DC76188G8</basicUdiDi>
    <tradeName>iStar-T4</tradeName>
    <deviceName>iStar-T4</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76188</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:07:04.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76186G4</udiDi>
    <basicUdiDi>B-DC76186G4</basicUdiDi>
    <tradeName>iStar-T4</tradeName>
    <deviceName>iStar-T4</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76186</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:06:50.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76056FN</udiDi>
    <basicUdiDi>B-DC76056FN</basicUdiDi>
    <tradeName>iStar-Tg</tradeName>
    <deviceName>iStar-Tg</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76056</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:36.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76005F5</udiDi>
    <basicUdiDi>B-DC76005F5</basicUdiDi>
    <tradeName>iStar-TSH</tradeName>
    <deviceName>iStar-TSH</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:25.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76004F3</udiDi>
    <basicUdiDi>B-DC76004F3</basicUdiDi>
    <tradeName>iStar-FT4</tradeName>
    <deviceName>iStar-FT4</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:23.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76003EZ</udiDi>
    <basicUdiDi>B-DC76003EZ</basicUdiDi>
    <tradeName>iStar-T4</tradeName>
    <deviceName>iStar-T4</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:23.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76002EX</udiDi>
    <basicUdiDi>B-DC76002EX</basicUdiDi>
    <tradeName>iStar-FT3</tradeName>
    <deviceName>iStar-FT3</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:21.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76001EV</udiDi>
    <basicUdiDi>B-DC76001EV</basicUdiDi>
    <tradeName>iStar-T3</tradeName>
    <deviceName>iStar-T3</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:19.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATPO706-AE79</udiDi>
    <basicUdiDi>B-ATPO706-AE79</basicUdiDi>
    <tradeName>A-TPO Antibody to Thyroid Peroxidase (CLIA)</tradeName>
    <deviceName>A-TPO Antibody to Thyroid Peroxidase (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATPO706-AE10Y, ATPO706-AE10N, ATPO706-AE20Y, ATPO706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:45:21.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATSHR706-AEGS</udiDi>
    <basicUdiDi>B-ATSHR706-AEGS</basicUdiDi>
    <tradeName>Anti-TSHR Antibody to Thyroid Stimulating Hormone Receptor (CLIA)</tradeName>
    <deviceName>Anti-TSHR Antibody to Thyroid Stimulating Hormone Receptor (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATSHR706-AE10Y, ATSHR706-AE10N, ATSHR706-AE20Y, ATSHR706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:45:19.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATG706-AEV9</udiDi>
    <basicUdiDi>B-ATG706-AEV9</basicUdiDi>
    <tradeName>A-TG Antibody to Thyroglobulin (CLIA)</tradeName>
    <deviceName>A-TG Antibody to Thyroglobulin (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATG706-AE10Y, ATG706-AE10N, ATG706-AE20Y, ATG706-AE20Y</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:45:04.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683981724374GA</udiDi>
    <basicUdiDi>B-8683981724374GA</basicUdiDi>
    <tradeName>INNOVIQURE - Free T3 KIT</tradeName>
    <deviceName>INNOVIQURE - Free T3 KIT</deviceName>
    <manufacturerName>DENİZ BİYOKİMYA ÜRÜNLERİ DIŞ TİC. A.Ş. GAZİEMİR İZMİR ŞUBESİ</manufacturerName>
    <manufacturerSrn>TR-MF-000034179</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>724374</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:27:10.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B11DA</udiDi>
    <basicUdiDi>B-7B11DA</basicUdiDi>
    <tradeName>Thyroid Globulin assay (CLIA)</tradeName>
    <deviceName>Thyroid Globulin assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B11V1-B-EU, 7B11U1-B-EU, 7B11P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:23.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B12DC</udiDi>
    <basicUdiDi>B-7B12DC</basicUdiDi>
    <tradeName>Thyrotropin Receptor Antibody assay (CLIA)</tradeName>
    <deviceName>Thyrotropin Receptor Antibody assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B12V1-B-EU, 7B12U1-B-EU, 7B12P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:22.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B07DK</udiDi>
    <basicUdiDi>B-7B07DK</basicUdiDi>
    <tradeName>Thyroid-Globulin Antibody assay (CLIA)</tradeName>
    <deviceName>Thyroid-Globulin Antibody assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B07V1-B-EU, 7B07U1-B-EU, 7B07P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:22.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B08DM</udiDi>
    <basicUdiDi>B-7B08DM</basicUdiDi>
    <tradeName>Thyroid-Peroxidase Antibody assay (CLIA)</tradeName>
    <deviceName>Thyroid-Peroxidase Antibody assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B08V1-B-EU, 7B08U1-B-EU, 7B08P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:22.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B05DF</udiDi>
    <basicUdiDi>B-7B05DF</basicUdiDi>
    <tradeName>Total Thyroxine assay (CLIA)</tradeName>
    <deviceName>Total Thyroxine assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B05V1-B-EU, 7B05U1-B-EU, 7B05P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:17.342Z</lastUpdated>
  </row>
</eudamedExport>