<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974854621213</udiDi>
    <basicUdiDi>B-06974854621213</basicUdiDi>
    <tradeName>Brain Natriuretic Peptide (BNP) Test</tradeName>
    <deviceName>Brain Natriuretic Peptide (BNP) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</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>P2207025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:27.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621206</udiDi>
    <basicUdiDi>B-06974854621206</basicUdiDi>
    <tradeName>NT-proBNP Test</tradeName>
    <deviceName>NT-proBNP Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</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>P2206925</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:27.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621190</udiDi>
    <basicUdiDi>B-06974854621190</basicUdiDi>
    <tradeName>Cardiac Troponin-T (cTnT) Test</tradeName>
    <deviceName>Cardiac Troponin-T (cTnT) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</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>P2206825</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:26.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621114</udiDi>
    <basicUdiDi>B-06974854621114</basicUdiDi>
    <tradeName>C Reactive Protein/Serum Amyloid A (CRP/SAA) Test</tradeName>
    <deviceName>C Reactive Protein/Serum Amyloid A (CRP/SAA) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</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>P2206125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:12.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621107</udiDi>
    <basicUdiDi>B-06974854621107</basicUdiDi>
    <tradeName>High Sensitivity C Reactive Protein+C Reactive Protein (hsCRP+CRP) Test</tradeName>
    <deviceName>High Sensitivity C Reactive Protein+C Reactive Protein (hsCRP+CRP) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2206025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:11.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621077</udiDi>
    <basicUdiDi>B-06974854621077</basicUdiDi>
    <tradeName>cTnI/CK-MB/Myo Rapid Test</tradeName>
    <deviceName>cTnI/CK-MB/Myo Rapid Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</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>P22057</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:54:21.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621060</udiDi>
    <basicUdiDi>B-06974854621060</basicUdiDi>
    <tradeName>Cardiac Troponin I(cTnI) Rapid Test</tradeName>
    <deviceName>Cardiac Troponin I(cTnI) Rapid Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</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>P22056</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:54:20.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129933</udiDi>
    <basicUdiDi>B-06974760129933</basicUdiDi>
    <tradeName>06974760129933</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 （Lp-PLA2）Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:17.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129865</udiDi>
    <basicUdiDi>B-06974760129865</basicUdiDi>
    <tradeName>06974760129865</tradeName>
    <deviceName>Ischemia Modified Albumin （IMA）Assay Kit （Albumin Cobalt Binding Method）</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021309</emdnCode>
    <emdnDescription>ISCHEMIA MODIFIED ALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:05.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129629</udiDi>
    <basicUdiDi>B-06974760129629</basicUdiDi>
    <tradeName>06974760129629</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2（Lp-PLA2） Assay Kit（Enzymatic Method）</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:12.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129599</udiDi>
    <basicUdiDi>B-06974760129599</basicUdiDi>
    <tradeName>06974760129599</tradeName>
    <deviceName>Homocysteine （HCY）Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL, Calibrator: 2×0.5 mL (2 levels, optional), Control: 2×0.5 mL (2 levels, optional)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:07.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129568</udiDi>
    <basicUdiDi>B-06974760129568</basicUdiDi>
    <tradeName>06974760129568</tradeName>
    <deviceName>Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:03.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129551</udiDi>
    <basicUdiDi>B-06974760129551</basicUdiDi>
    <tradeName>06974760129551</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:00.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129537</udiDi>
    <basicUdiDi>B-06974760129537</basicUdiDi>
    <tradeName>06974760129537</tradeName>
    <deviceName>Myeloperoxidase (MPO) Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021310</emdnCode>
    <emdnDescription>MYELOPEROXIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×45 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:58.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129506</udiDi>
    <basicUdiDi>B-06974760129506</basicUdiDi>
    <tradeName>06974760129506</tradeName>
    <deviceName>Myoglobin (MYO) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×45 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:52.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129315</udiDi>
    <basicUdiDi>B-06974760129315</basicUdiDi>
    <tradeName>06974760129315</tradeName>
    <deviceName>Full-Range C-Reactive Protein (fCRP) Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 1×16 mL, R2: 1×8 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:35.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974738205164</udiDi>
    <basicUdiDi>B-06974738205164</basicUdiDi>
    <tradeName>Heart-Type Fatty Acid-Binding Protein Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF16-01-40</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:11.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974738205157</udiDi>
    <basicUdiDi>B-06974738205157</basicUdiDi>
    <tradeName>Heart-Type Fatty Acid-Binding Protein Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF16-01-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:10.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974738205140</udiDi>
    <basicUdiDi>B-06974738205140</basicUdiDi>
    <tradeName>Myoglobin Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF15-01-40</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:09.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974738205133</udiDi>
    <basicUdiDi>B-06974738205133</basicUdiDi>
    <tradeName>Myoglobin Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF15-01-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:07.981Z</lastUpdated>
  </row>
</eudamedExport>