<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414962030</udiDi>
    <basicUdiDi>0405686901404V6</basicUdiDi>
    <tradeName>IMMULITE 2000 Rapid TSH</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Rapid TSH</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381652</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:27.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597171</udiDi>
    <basicUdiDi>0405686901415VB</basicUdiDi>
    <tradeName>IMMULITE 2000 TSI</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_TSI</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10713448</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:34.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238418</udiDi>
    <basicUdiDi>0405686901464VQ</basicUdiDi>
    <tradeName>Atellica IM Thyroglobulin (Tg)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Thyroglobulin</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020408</emdnCode>
    <emdnDescription>THYROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200450</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:28.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414535418</udiDi>
    <basicUdiDi>0405686900788WE</basicUdiDi>
    <tradeName>ADVIA Centaur® FT4</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_FT4</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10282218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:43.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID6439</udiDi>
    <basicUdiDi>B-VID6439</basicUdiDi>
    <tradeName>Free Triiodothyronine Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID64-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:20.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID6337</udiDi>
    <basicUdiDi>B-VID6337</basicUdiDi>
    <tradeName>Free Thyroxine Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID63-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:20.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID222R</udiDi>
    <basicUdiDi>B-VID222R</basicUdiDi>
    <tradeName>Thyroxine Test Kit (FIA)</tradeName>
    <deviceName>Thyroxine Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID22-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:27.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID212P</udiDi>
    <basicUdiDi>B-VID212P</basicUdiDi>
    <tradeName>Triiodothyronine Test Kit (FIA)</tradeName>
    <deviceName>Triiodothyronine Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID21-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:23.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID202M</udiDi>
    <basicUdiDi>B-VID202M</basicUdiDi>
    <tradeName>Thyroid Stimulating Hormone Test Kit (FIA)</tradeName>
    <deviceName>Thyroid Stimulating Hormone Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID20-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:21:02.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID140ER</udiDi>
    <basicUdiDi>B-VID140ER</basicUdiDi>
    <tradeName>Thyroglobulin Antibody Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID140-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:49.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TT4706-AEZC</udiDi>
    <basicUdiDi>B-TT4706-AEZC</basicUdiDi>
    <tradeName>T4 Total Thyroxine (CLIA)</tradeName>
    <deviceName>T4 Total Thyroxine (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>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT4706-AE10Y, TT4706-AE10N, TT4706-AE20Y, TT4706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:24:05.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TT3706-AEYT</udiDi>
    <basicUdiDi>B-TT3706-AEYT</basicUdiDi>
    <tradeName>T3 Total Triiodothyronine (CLIA)</tradeName>
    <deviceName>T3 Total Triiodothyronine (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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT3706-AE10Y, TT3706-AE10N, TT3706-AE20Y, TT3706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:24:04.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TSH706-AEAX</udiDi>
    <basicUdiDi>B-TSH706-AEAX</basicUdiDi>
    <tradeName>TSH Thyroid Stimulating Hormone (CLIA)</tradeName>
    <deviceName>TSH Thyroid Stimulating Hormone (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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSH706-AE10Y, TSH706-AE10N, TSH706-AE20Y, TSH706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:52.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TG706-AE8E</udiDi>
    <basicUdiDi>B-TG706-AE8E</basicUdiDi>
    <tradeName>Tg Thyroglobulin (CLIA)</tradeName>
    <deviceName>Tg 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>TG706-AE10Y, TG706-AE10N, TG706-AE20Y, TG706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:38.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-634D</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-634D</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-634D</tradeName>
    <deviceName>Free Thyroxine Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:36.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-624B</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-624B</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-624B</tradeName>
    <deviceName>Free Triiodothyronine Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:35.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-033T</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-033T</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-033T</tradeName>
    <deviceName>Total Thyroxine Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:29.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-023R</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-023R</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-023R</tradeName>
    <deviceName>Total Triiodothyronine Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:27.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-013P</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-013P</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-013P</tradeName>
    <deviceName>Thyroid Stimulating Hormone Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:26.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Q00209YK</udiDi>
    <basicUdiDi>B-Q00209YK</basicUdiDi>
    <tradeName>D-Q00209YK</tradeName>
    <deviceName>FT4</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q00209</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:22:56.719Z</lastUpdated>
  </row>
</eudamedExport>