<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-6-89B4</udiDi>
    <basicUdiDi>B-6-89B4</basicUdiDi>
    <tradeName>D-6-89B4</tradeName>
    <deviceName>High-sensitive Cardiac Troponin T (hs-cTnT) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000081M, USIA00000082M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:51.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-87AY</udiDi>
    <basicUdiDi>B-6-87AY</basicUdiDi>
    <tradeName>D-6-87AY</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000079M, USIA00000080M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:42.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-133FF</udiDi>
    <basicUdiDi>B-6-133FF</basicUdiDi>
    <tradeName>D-6-133FF</tradeName>
    <deviceName>Cardiac troponin I (cTnI ) Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000740, USCA00000743 USCA00000741, USCA00000742 USCA00000744, USCA00000781"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:50.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139071724</udiDi>
    <basicUdiDi>69703416803205080JK</basicUdiDi>
    <tradeName>hs-cTnI STAT (eCLIA)</tradeName>
    <deviceName>hs-cTnI STAT (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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320513401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:59.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595301179</udiDi>
    <basicUdiDi>4987595PF1241KXP</basicUdiDi>
    <tradeName>PATHFAST hs-cTnI</tradeName>
    <deviceName>PATHFAST hs-cTnI</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30117</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:46.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595301117</udiDi>
    <basicUdiDi>4987595PF1011KWS</basicUdiDi>
    <tradeName>PATHFAST cTnI</tradeName>
    <deviceName>PATHFAST cTnI</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30111</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:44.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414962122</udiDi>
    <basicUdiDi>0405686901467VW</basicUdiDi>
    <tradeName>IMMULITE 2000 Troponin I</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Troponin I</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:28.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414006703</udiDi>
    <basicUdiDi>0405686900809VV</basicUdiDi>
    <tradeName>Atellica IM High‑Sensitivity Troponin I (TnIH)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_TnIH</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10997840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:12:42.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768037726</udiDi>
    <basicUdiDi>0405686900216UU</basicUdiDi>
    <tradeName>Dimension EXL LOCI High Sensitivity Troponin I Flex Reagent Cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TNIH</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10471068</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:53.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-hs-cTnT706-AE3N</udiDi>
    <basicUdiDi>B-hs-cTnT706-AE3N</basicUdiDi>
    <tradeName>cTn-T  Cardiac Troponin T (CLIA)</tradeName>
    <deviceName>cTn-T  Cardiac Troponin T (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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>hs-cTnT706-AE10Y, hs-cTnT706-AE10N, hs-cTnT706-AE20Y, hs-cTnT706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:48.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-hs-cTnI706-AEVQ</udiDi>
    <basicUdiDi>B-hs-cTnI706-AEVQ</basicUdiDi>
    <tradeName>cTn-I Cardiac Troponin I  (CLIA)</tradeName>
    <deviceName>cTn-I Cardiac Troponin I  (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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>hs-cTnI706-AE10Y, hs-cTnI706-AE10N, hs-cTnI706-AE20Y, hs-cTnI706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:48.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-hs-cTnI/CK-MB63</udiDi>
    <basicUdiDi>B-hs-cTnI/CK-MB63</basicUdiDi>
    <tradeName>hs-cTnI/CK-MB (CLIA)</tradeName>
    <deviceName>hs-cTnI/CK-MB (CLIA)</deviceName>
    <manufacturerName>DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000042193</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit:(Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:28.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-cTnI601RE</udiDi>
    <basicUdiDi>B-cTnI601RE</basicUdiDi>
    <tradeName>Cardiac Troponin I Reagent Kit</tradeName>
    <deviceName>Cardiac Troponin I Reagent Kit</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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>cTnI6011Y, cTnI6012Y, cTnI6013Y, cTnI6014Y, cTnI6015Y, cTnI6011N, cTnI6012N, cTnI6013N, cTnI6014N, cTnI6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:10.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID113EN</udiDi>
    <basicUdiDi>B-VID113EN</basicUdiDi>
    <tradeName>VivaDiag High Sensitive Cardiac Troponin I Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag High Sensitive Cardiac Troponin I Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID113-03-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:10.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-223X</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-223X</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-223X</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:02.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK014DH</udiDi>
    <basicUdiDi>B-SEK014DH</basicUdiDi>
    <tradeName>hs-cTnI Assay Kit (ECLIA)</tradeName>
    <deviceName>hs-cTnI Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:49.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK013DF</udiDi>
    <basicUdiDi>B-SEK013DF</basicUdiDi>
    <tradeName>hs-cTnT Assay Kit (ECLIA)</tradeName>
    <deviceName>hs-cTnT Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:48.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22214ZV</udiDi>
    <basicUdiDi>B-R22214ZV</basicUdiDi>
    <tradeName>D-R22214ZV</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin T (hs-cTnT) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:26.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22213ZT</udiDi>
    <basicUdiDi>B-R22213ZT</basicUdiDi>
    <tradeName>D-R22213ZT</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin T (hs-cTnT) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:25.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R22212ZR</udiDi>
    <basicUdiDi>B-R22212ZR</basicUdiDi>
    <tradeName>D-R22212ZR</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin T (hs-cTnT) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22212</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:24.816Z</lastUpdated>
  </row>
</eudamedExport>