<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-VID342Y</udiDi>
    <basicUdiDi>B-VID342Y</basicUdiDi>
    <tradeName>Homocysteine Test Kit (FIA)</tradeName>
    <deviceName></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>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID34-03-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:40.062Z</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-654H</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-654H</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-654H</tradeName>
    <deviceName>Myoglobin 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:42.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-644F</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-644F</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-644F</tradeName>
    <deviceName>Creatine Kinase Myocardial Isoenzyme 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:42.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-6047</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-6047</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-6047</tradeName>
    <deviceName>Homocysteine 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>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:33.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-4449</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-4449</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-4449</tradeName>
    <deviceName>Myeloperoxidase 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>W01021310</emdnCode>
    <emdnDescription>MYELOPEROXIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:52.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-4143</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-4143</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-4143</tradeName>
    <deviceName>Soluble Growth Stimulation Gene-2 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>W01021314</emdnCode>
    <emdnDescription>ST2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:47.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-364A</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-364A</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-364A</tradeName>
    <deviceName>Multiple (9 Items) Cardiac Marker 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:38.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-2647</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-2647</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-2647</tradeName>
    <deviceName>N-terminal proBNP 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:23.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-2545</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-2545</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-2545</tradeName>
    <deviceName>B-type Natriuretic Protein 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:22.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-2749</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-2749</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-2749</tradeName>
    <deviceName>DISKFLU Multiple Cardiac Marker 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:21.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-233Z</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-233Z</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-233Z</tradeName>
    <deviceName>LYOFIA Multiple Cardiac Marker 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:02.952Z</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-ST2706-AEXK</udiDi>
    <basicUdiDi>B-ST2706-AEXK</basicUdiDi>
    <tradeName>ST2 Growth Stimulation Expressed gene 2 (CLIA)</tradeName>
    <deviceName>ST2 Growth Stimulation Expressed gene 2 (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>W01021314</emdnCode>
    <emdnDescription>ST2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST2706-AE10Y, ST2706-AE10N, ST2706-AE20Y, ST2706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:44:34.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK021DE</udiDi>
    <basicUdiDi>B-SEK021DE</basicUdiDi>
    <tradeName>BNP Assay Kit (ECLIA)</tradeName>
    <deviceName>BNP 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:13:00.895Z</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>
</eudamedExport>