<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-KR-FT3-05100KC</udiDi>
    <basicUdiDi>B-KR-FT3-05100KC</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-05100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:20.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-04100K5</udiDi>
    <basicUdiDi>B-KR-FT3-04100K5</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-04100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:19.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-03100JW</udiDi>
    <basicUdiDi>B-KR-FT3-03100JW</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-03100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:18.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-0250QD</udiDi>
    <basicUdiDi>B-KR-FT3-0250QD</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:14.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-02300JZ</udiDi>
    <basicUdiDi>B-KR-FT3-02300JZ</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-02300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:13.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-02200JU</udiDi>
    <basicUdiDi>B-KR-FT3-02200JU</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:12.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-02100JP</udiDi>
    <basicUdiDi>B-KR-FT3-02100JP</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-02100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:12.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-01200JM</udiDi>
    <basicUdiDi>B-KR-FT3-01200JM</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-01200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:08.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-01100CMW</udiDi>
    <basicUdiDi>B-KR-FT3-01100CMW</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:07.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-0150Q8</udiDi>
    <basicUdiDi>B-KR-FT3-0150Q8</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-0150</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:06.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FT3-01300JS</udiDi>
    <basicUdiDi>B-KR-FT3-01300JS</basicUdiDi>
    <tradeName>INNODX FT3 CMIA</tradeName>
    <deviceName>INNODX FT3 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FT3-01300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:05.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406052JD</udiDi>
    <basicUdiDi>B-IM4406052JD</basicUdiDi>
    <tradeName>D-IM4406052JD</tradeName>
    <deviceName>FT3 (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:25:35.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4405052J6</udiDi>
    <basicUdiDi>B-IM4405052J6</basicUdiDi>
    <tradeName>D-IM4405052J6</tradeName>
    <deviceName>FT3 (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4405052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:24:28.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4404052HX</udiDi>
    <basicUdiDi>B-IM4404052HX</basicUdiDi>
    <tradeName>D-IM4404052HX</tradeName>
    <deviceName>FT3 (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4404052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:23:36.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403052HQ</udiDi>
    <basicUdiDi>B-IM4403052HQ</basicUdiDi>
    <tradeName>D-IM4403052HQ</tradeName>
    <deviceName>FT3 (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:26.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402052HH</udiDi>
    <basicUdiDi>B-IM4402052HH</basicUdiDi>
    <tradeName>D-IM4402052HH</tradeName>
    <deviceName>FT3 (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:12.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4401052HA</udiDi>
    <basicUdiDi>B-IM4401052HA</basicUdiDi>
    <tradeName>D-IM4401052HA</tradeName>
    <deviceName>FT3 (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4401052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:15:35.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD169Y2</udiDi>
    <basicUdiDi>B-GKPD169Y2</basicUdiDi>
    <tradeName>FT3 Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>FT3 Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD169</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:16.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FT3706-AENR</udiDi>
    <basicUdiDi>B-FT3706-AENR</basicUdiDi>
    <tradeName>FT3 Free Triiodothyronine (CLIA)</tradeName>
    <deviceName>FT3 Free 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>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT3706-AE10Y, FT3706-AE10N, FT3706-AE20Y, FT3706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:24:27.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTT3-402aHG9G</udiDi>
    <basicUdiDi>B-FKTT3-402aHG9G</basicUdiDi>
    <tradeName>T3 Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</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>FKTT3-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:12.431Z</lastUpdated>
  </row>
</eudamedExport>