<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-KR-TSH-071007Y</udiDi>
    <basicUdiDi>B-KR-TSH-071007Y</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-07100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:46.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-061007R</udiDi>
    <basicUdiDi>B-KR-TSH-061007R</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-06100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:44.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-051007J</udiDi>
    <basicUdiDi>B-KR-TSH-051007J</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-05100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:41.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-041007B</udiDi>
    <basicUdiDi>B-KR-TSH-041007B</basicUdiDi>
    <tradeName>D-KR-TSH-041007B</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-04100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:41.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-02508D</udiDi>
    <basicUdiDi>B-KR-TSH-02508D</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:39.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-0230077</udiDi>
    <basicUdiDi>B-KR-TSH-0230077</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-02300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:37.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-0220072</udiDi>
    <basicUdiDi>B-KR-TSH-0220072</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:35.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-021006V</udiDi>
    <basicUdiDi>B-KR-TSH-021006V</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-02100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:34.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-015088</udiDi>
    <basicUdiDi>B-KR-TSH-015088</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-0150</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:33.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-013006Y</udiDi>
    <basicUdiDi>B-KR-TSH-013006Y</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-01300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:29.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-012006T</udiDi>
    <basicUdiDi>B-KR-TSH-012006T</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-01200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:28.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TSH-01100CDU</udiDi>
    <basicUdiDi>B-KR-TSH-01100CDU</basicUdiDi>
    <tradeName>INNODX TSH CMIA</tradeName>
    <deviceName>INNODX TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TSH-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:27.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-013P6</udiDi>
    <basicUdiDi>B-K90411-013P6</basicUdiDi>
    <tradeName>D-K90411-013P6</tradeName>
    <deviceName>Thyroid Stimulating Hormone(TSH) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:16.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTSH-402bFH</udiDi>
    <basicUdiDi>B-FKTSH-402bFH</basicUdiDi>
    <tradeName>TSH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>TSH Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>FKTSH-402b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:08.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTSH-402aHGLM</udiDi>
    <basicUdiDi>B-FKTSH-402aHGLM</basicUdiDi>
    <tradeName>TSH 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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTSH-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:07.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTSH-402bHGLS</udiDi>
    <basicUdiDi>B-FKTSH-402bHGLS</basicUdiDi>
    <tradeName>TSH Quantitative Test Kit (Time-Resolved FIA)-20ul</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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTSH-402b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:05.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTSH-402aFF</udiDi>
    <basicUdiDi>B-FKTSH-402aFF</basicUdiDi>
    <tradeName>TSH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>TSH Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>FKTSH-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:48.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FA0003YW</udiDi>
    <basicUdiDi>B-FA0003YW</basicUdiDi>
    <tradeName>Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</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>52027016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:22.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4205055FJ</udiDi>
    <basicUdiDi>B-EIM4205055FJ</basicUdiDi>
    <tradeName>D-EIM4205055FJ</tradeName>
    <deviceName>TSH</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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4205055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:52:43.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4203055F4</udiDi>
    <basicUdiDi>B-EIM4203055F4</basicUdiDi>
    <tradeName>D-EIM4203055F4</tradeName>
    <deviceName>TSH</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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4203055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:52:16.307Z</lastUpdated>
  </row>
</eudamedExport>