<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76222FF</udiDi>
    <basicUdiDi>B-DC76222FF</basicUdiDi>
    <tradeName>iStar-T3</tradeName>
    <deviceName>iStar-T3</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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76222</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:08:14.903Z</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-7B04DD</udiDi>
    <basicUdiDi>B-7B04DD</basicUdiDi>
    <tradeName>Total Triiodothyronine assay (CLIA)</tradeName>
    <deviceName>Total Triiodothyronine 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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B04V1-B-EU, 7B04U1-B-EU, 7B04P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:16.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3146W</udiDi>
    <basicUdiDi>B-3146W</basicUdiDi>
    <tradeName>D-3146W</tradeName>
    <deviceName>Total Triiodothyronine Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:17:26.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3029AC</udiDi>
    <basicUdiDi>B-3029AC</basicUdiDi>
    <tradeName>D-3029AC</tradeName>
    <deviceName>Total Triiodothyronine in vitro diagnostic kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Aikang Diagnostics Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028962</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3029030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:37.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346038</udiDi>
    <basicUdiDi>B-20850076346038</basicUdiDi>
    <tradeName>Total Triiodothyronine Test Kit (CLIA)</tradeName>
    <deviceName>Total Triiodothyronine Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</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>CKTT3-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:02:15.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723073</udiDi>
    <basicUdiDi>692591270004GR</basicUdiDi>
    <tradeName>iFlash-T3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86025-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763556</udiDi>
    <basicUdiDi>B-15065023763556</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>T3 Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</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>TV20017</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:47.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185395454</udiDi>
    <basicUdiDi>B-14562185395454</basicUdiDi>
    <tradeName>14562185395454</tradeName>
    <deviceName>CL AIA-PACK T3 ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029204</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:06.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185395447</udiDi>
    <basicUdiDi>B-14562185395447</basicUdiDi>
    <tradeName>14562185395447</tradeName>
    <deviceName>CL AIA-PACK T3 TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029104</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:06.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189210339</udiDi>
    <basicUdiDi>B-14560189210339</basicUdiDi>
    <tradeName>14560189210339</tradeName>
    <deviceName>ST AIA-PACK TT3</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025282</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:01:21.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346031</udiDi>
    <basicUdiDi>B-10850076346031</basicUdiDi>
    <tradeName>Total Triiodothyronine Test Kit (CLIA)</tradeName>
    <deviceName>Total Triiodothyronine Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</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>CKTT3-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:29.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595039311</udiDi>
    <basicUdiDi>B-08684595039311</basicUdiDi>
    <tradeName>RapidFor™ T3 Rapid Test Kit (FIA)</tradeName>
    <deviceName>T3 Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO02FC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:17:47.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250131</udiDi>
    <basicUdiDi>B-08683548250131</basicUdiDi>
    <tradeName>RapidFor™T3 Rapid Test Kit (FIA)</tradeName>
    <deviceName>T3 Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:07:53.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359541480</udiDi>
    <basicUdiDi>697015090000001GJ</basicUdiDi>
    <tradeName>T3 CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:20.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034049110446</udiDi>
    <basicUdiDi>B-08034049110446</basicUdiDi>
    <tradeName>08034049110446</tradeName>
    <deviceName>T3 ELISA</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO044</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:30.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034049110378</udiDi>
    <basicUdiDi>B-08034049110378</basicUdiDi>
    <tradeName>08034049110378</tradeName>
    <deviceName>FT3 ELISA</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO037</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:28.203Z</lastUpdated>
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  <row>
    <udiDi>06979878281023</udiDi>
    <basicUdiDi>B-06979878281023</basicUdiDi>
    <tradeName>06979878281023</tradeName>
    <deviceName>Triiodothyronine Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:01.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355927369</udiDi>
    <basicUdiDi>B-06979355927369</basicUdiDi>
    <tradeName>06979355927369</tradeName>
    <deviceName>Total triiodothyronine (TT3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:28:56.967Z</lastUpdated>
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  <row>
    <udiDi>06979355927352</udiDi>
    <basicUdiDi>B-06979355927352</basicUdiDi>
    <tradeName>06979355927352</tradeName>
    <deviceName>Total triiodothyronine (TT3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:28:52.968Z</lastUpdated>
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</eudamedExport>