<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>D-SEK012DD</udiDi>
    <basicUdiDi>B-SEK012DD</basicUdiDi>
    <tradeName>CKMB Assay Kit (ECLIA)</tradeName>
    <deviceName>CKMB 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>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:44.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK011DB</udiDi>
    <basicUdiDi>B-SEK011DB</basicUdiDi>
    <tradeName>NT-proBNP Assay Kit (ECLIA)</tradeName>
    <deviceName>NT-proBNP 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-K011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:43.275Z</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>
  <row>
    <udiDi>D-R22211ZP</udiDi>
    <basicUdiDi>B-R22211ZP</basicUdiDi>
    <tradeName>D-R22211ZP</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>R22211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:24.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OMOCISTEINA-LRWD</udiDi>
    <basicUdiDi>B-OMOCISTEINA-LRWD</basicUdiDi>
    <tradeName>OMOCISTEINA LR</tradeName>
    <deviceName>OMOCISTEINA LR</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC243-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:14:52.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NT-proBNP706-AE3K</udiDi>
    <basicUdiDi>B-NT-proBNP706-AE3K</basicUdiDi>
    <tradeName>NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (CLIA)</tradeName>
    <deviceName>NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT-proBNP706-AE10Y, NT-proBNP706-AE10N, NT-proBNP706-AE20Y, NT-proBNP706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:07:18.759Z</lastUpdated>
  </row>
</eudamedExport>