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<eudamedExport entity="devices">
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    <udiDi>06975984063850</udiDi>
    <basicUdiDi>69703416803205088K3</basicUdiDi>
    <tradeName>Anti-TSHR (eCLIA)</tradeName>
    <deviceName>Anti-TSHR (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:09.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359541763</udiDi>
    <basicUdiDi>697015090000118H8</basicUdiDi>
    <tradeName>TRAb CLIA Microparticles</tradeName>
    <deviceName>TRAb CLIA Microparticles</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>IVDR 2017/746</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME1003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:01.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912718758</udiDi>
    <basicUdiDi>692591270007GX</basicUdiDi>
    <tradeName>iFlash-Anti-TSHR</tradeName>
    <deviceName>iFlash-Anti-TSHR</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>IVDR 2017/746</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:32:17.375Z</lastUpdated>
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  <row>
    <udiDi>04260157631823</udiDi>
    <basicUdiDi>426015763801BTRAKhumKXXMX</basicUdiDi>
    <tradeName>B·R·A·H·M·S TRAK human KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S TRAK human KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801050N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:48.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TRAb-04100Y3</udiDi>
    <basicUdiDi>B-KR-TRAb-04100Y3</basicUdiDi>
    <tradeName>INNODX TRAb CMIA</tradeName>
    <deviceName>INNODX TRAb 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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TRAb-04100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:25.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TRAb-0250LT</udiDi>
    <basicUdiDi>B-KR-TRAb-0250LT</basicUdiDi>
    <tradeName>INNODX TRAb CMIA</tradeName>
    <deviceName>INNODX TRAb 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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TRAb-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:23.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TRAb-02200XS</udiDi>
    <basicUdiDi>B-KR-TRAb-02200XS</basicUdiDi>
    <tradeName>INNODX TRAb CMIA</tradeName>
    <deviceName>INNODX TRAb 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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TRAb-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:21.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TRAb-01100XE</udiDi>
    <basicUdiDi>B-KR-TRAb-01100XE</basicUdiDi>
    <tradeName>INNODX TRAb CMIA</tradeName>
    <deviceName>INNODX TRAb 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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TRAb-01100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:21.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406055JK</udiDi>
    <basicUdiDi>B-IM4406055JK</basicUdiDi>
    <tradeName>D-IM4406055JK</tradeName>
    <deviceName>TSH (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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:25:38.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4405055JC</udiDi>
    <basicUdiDi>B-IM4405055JC</basicUdiDi>
    <tradeName>D-IM4405055JC</tradeName>
    <deviceName>TSH (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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4405055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:24:30.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4404055J5</udiDi>
    <basicUdiDi>B-IM4404055J5</basicUdiDi>
    <tradeName>D-IM4404055J5</tradeName>
    <deviceName>TSH (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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4404055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:23:39.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403055HW</udiDi>
    <basicUdiDi>B-IM4403055HW</basicUdiDi>
    <tradeName>D-IM4403055HW</tradeName>
    <deviceName>TSH (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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:31.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402055HP</udiDi>
    <basicUdiDi>B-IM4402055HP</basicUdiDi>
    <tradeName>D-IM4402055HP</tradeName>
    <deviceName>TSH (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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:17.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4401055HG</udiDi>
    <basicUdiDi>B-IM4401055HG</basicUdiDi>
    <tradeName>D-IM4401055HG</tradeName>
    <deviceName>TSH (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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4401055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:15:37.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76376GB</udiDi>
    <basicUdiDi>B-DC76376GB</basicUdiDi>
    <tradeName>iStar-Anti-TSHR</tradeName>
    <deviceName>iStar-Anti-TSHR</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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76376</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:28.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76375G9</udiDi>
    <basicUdiDi>B-DC76375G9</basicUdiDi>
    <tradeName>iStar-Anti-TSHR</tradeName>
    <deviceName>iStar-Anti-TSHR</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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76375</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:27.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76374G7</udiDi>
    <basicUdiDi>B-DC76374G7</basicUdiDi>
    <tradeName>iStar-Anti-TSHR</tradeName>
    <deviceName>iStar-Anti-TSHR</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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76374</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:26.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76373G5</udiDi>
    <basicUdiDi>B-DC76373G5</basicUdiDi>
    <tradeName>iStar-Anti-TSHR</tradeName>
    <deviceName>iStar-Anti-TSHR</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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76373</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:22.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76058FS</udiDi>
    <basicUdiDi>B-DC76058FS</basicUdiDi>
    <tradeName>iStar-Anti-TSHR</tradeName>
    <deviceName>iStar-Anti-TSHR</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>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76058</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:39.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC370QN</udiDi>
    <basicUdiDi>B-CC370QN</basicUdiDi>
    <tradeName>Anti-TSHR Control</tradeName>
    <deviceName>Anti-TSHR Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC370</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:56:18.135Z</lastUpdated>
  </row>
</eudamedExport>