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<eudamedExport entity="devices">
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    <udiDi>06942359542166</udiDi>
    <basicUdiDi>697015090000025GY</basicUdiDi>
    <tradeName>PTH 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>IVDR 2017/746</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME0903</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:09.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157632103</udiDi>
    <basicUdiDi>426015763832BhTgsensKXXE2</basicUdiDi>
    <tradeName>B·R·A·H·M·S hTg sensitive KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S hTg sensitive KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>832075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:14.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590201623</udiDi>
    <basicUdiDi>150995901AccTPOAbN2</basicUdiDi>
    <tradeName>Access TPO Antibody</tradeName>
    <deviceName>Access TPO Antibody</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A12985</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:32:00.344Z</lastUpdated>
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  <row>
    <udiDi>00842768013683</udiDi>
    <basicUdiDi>0405686901198VS</basicUdiDi>
    <tradeName>Dimension Thyroid Calibrator</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_THY CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</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>10445018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:02.706Z</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>D-KR-iPTH-0250YP</udiDi>
    <basicUdiDi>B-KR-iPTH-0250YP</basicUdiDi>
    <tradeName>INNODX iPTH CMIA</tradeName>
    <deviceName>INNODX iPTH 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-iPTH-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:31.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-iPTH-02200D3</udiDi>
    <basicUdiDi>B-KR-iPTH-02200D3</basicUdiDi>
    <tradeName>D-KR-iPTH-02200D3</tradeName>
    <deviceName>INNODX iPTH 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-iPTH-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:27.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-iPTH-01100CP</udiDi>
    <basicUdiDi>B-KR-iPTH-01100CP</basicUdiDi>
    <tradeName>INNODX iPTH CMIA</tradeName>
    <deviceName>INNODX iPTH 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-iPTH-01100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:26.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATPO706-AE79</udiDi>
    <basicUdiDi>B-ATPO706-AE79</basicUdiDi>
    <tradeName>A-TPO Antibody to Thyroid Peroxidase (CLIA)</tradeName>
    <deviceName>A-TPO Antibody to Thyroid Peroxidase (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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATPO706-AE10Y, ATPO706-AE10N, ATPO706-AE20Y, ATPO706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:45:21.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ATSHR706-AEGS</udiDi>
    <basicUdiDi>B-ATSHR706-AEGS</basicUdiDi>
    <tradeName>Anti-TSHR Antibody to Thyroid Stimulating Hormone Receptor (CLIA)</tradeName>
    <deviceName>Anti-TSHR Antibody to Thyroid Stimulating Hormone Receptor (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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATSHR706-AE10Y, ATSHR706-AE10N, ATSHR706-AE20Y, ATSHR706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:45:19.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B11DA</udiDi>
    <basicUdiDi>B-7B11DA</basicUdiDi>
    <tradeName>Thyroid Globulin assay (CLIA)</tradeName>
    <deviceName>Thyroid Globulin 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B11V1-B-EU, 7B11U1-B-EU, 7B11P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:23.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B12DC</udiDi>
    <basicUdiDi>B-7B12DC</basicUdiDi>
    <tradeName>Thyrotropin Receptor Antibody assay (CLIA)</tradeName>
    <deviceName>Thyrotropin Receptor Antibody 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B12V1-B-EU, 7B12U1-B-EU, 7B12P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:22.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B07DK</udiDi>
    <basicUdiDi>B-7B07DK</basicUdiDi>
    <tradeName>Thyroid-Globulin Antibody assay (CLIA)</tradeName>
    <deviceName>Thyroid-Globulin Antibody 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B07V1-B-EU, 7B07U1-B-EU, 7B07P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:22.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7B08DM</udiDi>
    <basicUdiDi>B-7B08DM</basicUdiDi>
    <tradeName>Thyroid-Peroxidase Antibody assay (CLIA)</tradeName>
    <deviceName>Thyroid-Peroxidase Antibody 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7B08V1-B-EU, 7B08U1-B-EU, 7B08P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:22.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998271837</udiDi>
    <basicUdiDi>B-08684998271837</basicUdiDi>
    <tradeName>RapidFor™ TSH/T4/T3 (FIA)</tradeName>
    <deviceName>TSH/T4/T3 (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:09.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359542180</udiDi>
    <basicUdiDi>697015090000025GY</basicUdiDi>
    <tradeName>PTH 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>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME0905</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:20.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640146270009</udiDi>
    <basicUdiDi>B-07640146270009</basicUdiDi>
    <tradeName>07640146270009</tradeName>
    <deviceName>TECO® TSH Receptor Autoantibody ELISA Kit</deviceName>
    <manufacturerName>TECOmedical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000030341</manufacturerSrn>
    <authorisedRepresentativeName>EUROBIO SCIENTIFIC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000023178</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE1010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:58:08.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424226845</udiDi>
    <basicUdiDi>B-06975424226845</basicUdiDi>
    <tradeName>PTH CLIA Assay Kit</tradeName>
    <deviceName>PTH CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20792EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:24.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424226838</udiDi>
    <basicUdiDi>B-06975424226838</basicUdiDi>
    <tradeName>TPOAb CLIA Assay Kit</tradeName>
    <deviceName>TPOAb CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20752EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:23.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424226821</udiDi>
    <basicUdiDi>B-06975424226821</basicUdiDi>
    <tradeName>TGAb CLIA Assay Kit</tradeName>
    <deviceName>TGAb CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20802EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:22.845Z</lastUpdated>
  </row>
</eudamedExport>