<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GKPD162XL</udiDi>
    <basicUdiDi>B-GKPD162XL</basicUdiDi>
    <tradeName>CRP/ SAA Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>CRP/ SAA Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD162</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:54.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD161XJ</udiDi>
    <basicUdiDi>B-GKPD161XJ</basicUdiDi>
    <tradeName>hs-cTnI / Myo / CK-MB Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>hs-cTnI / Myo / CK-MB Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:52.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD134XF</udiDi>
    <basicUdiDi>B-GKPD134XF</basicUdiDi>
    <tradeName>cTnI / Myoglobin / CK-MB Triplex Rapid Test Kit</tradeName>
    <deviceName>cTnI / Myoglobin / CK-MB Triplex Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:11.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDCAR-W435aHGDL</udiDi>
    <basicUdiDi>B-GDCAR-W435aHGDL</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCAR-W435a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:27.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDCAR-335aHGRS</udiDi>
    <basicUdiDi>B-GDCAR-335aHGRS</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCAR-335a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:23.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMC-D06a8R</udiDi>
    <basicUdiDi>B-CMC-D06a8R</basicUdiDi>
    <tradeName>cTnI/CK-MB/MYO Test Kit FIA</tradeName>
    <deviceName>cTnI/CK-MB/MYO Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMC-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:08:46.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808171QK</udiDi>
    <basicUdiDi>B-808171QK</basicUdiDi>
    <tradeName>D-808171QK</tradeName>
    <deviceName>cTnI/DD/BNP Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808171</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:11.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808165QQ</udiDi>
    <basicUdiDi>B-808165QQ</basicUdiDi>
    <tradeName>D-808165QQ</tradeName>
    <deviceName>cTnI/MYO/CK-MB Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808165</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:59.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763471</udiDi>
    <basicUdiDi>B-15065023763471</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>CK-MB/cTnI/Myo Combo Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:21.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250469</udiDi>
    <basicUdiDi>B-08683548250469</basicUdiDi>
    <tradeName>RapidFor™ cTnI/Myo/CK-MB (FIA)</tradeName>
    <deviceName>cTnI/Myo/CK-MB (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:21.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977981880157</udiDi>
    <basicUdiDi>B-06977981880157</basicUdiDi>
    <tradeName>Cardiac Troponin I/Creatine Kinase-MB/Myoglobin Test Kit (QDs-FICA)</tradeName>
    <deviceName>Cardiac Troponin I/Creatine Kinase-MB/Myoglobin Test Kit (QDs-FICA)</deviceName>
    <manufacturerName>Chongqing Juce Life Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053774</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA0901</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:37:24.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977981880102</udiDi>
    <basicUdiDi>B-06977981880102</basicUdiDi>
    <tradeName>N-Terminal pro–B-type Natriuretic Peptide/Cardiac Troponin I/D-dimer Test Kit (QDs-FICA)</tradeName>
    <deviceName>N-Terminal pro–B-type Natriuretic Peptide/Cardiac Troponin I/D-dimer Test Kit (QDs-FICA)</deviceName>
    <manufacturerName>Chongqing Juce Life Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053774</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:37:17.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903346327</udiDi>
    <basicUdiDi>B-06977903346327</basicUdiDi>
    <tradeName>06977903346327</tradeName>
    <deviceName>cTnI/CK-MB/Myo FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS120705C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:39.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903346310</udiDi>
    <basicUdiDi>B-06977903346310</basicUdiDi>
    <tradeName>06977903346310</tradeName>
    <deviceName>cTnI/CK-MB/Myo FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS120705C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:38.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903342220</udiDi>
    <basicUdiDi>B-06977903342220</basicUdiDi>
    <tradeName>06977903342220</tradeName>
    <deviceName>Troponin I/Myoglobin/CK-MB Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110603C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:15.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903342213</udiDi>
    <basicUdiDi>B-06977903342213</basicUdiDi>
    <tradeName>06977903342213</tradeName>
    <deviceName>Troponin I/Myoglobin/CK-MB Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110603C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:15.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698402901</udiDi>
    <basicUdiDi>B-06977698402901</basicUdiDi>
    <tradeName>NT-proBNP Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography</tradeName>
    <deviceName>NT-proBNP Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD057</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:06.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698402840</udiDi>
    <basicUdiDi>B-06977698402840</basicUdiDi>
    <tradeName>Creatine Kinase MB Isoenzyme (CK-MB) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)</tradeName>
    <deviceName>Creatine Kinase MB Isoenzyme (CK-MB) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD055</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:04.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698402789</udiDi>
    <basicUdiDi>B-06977698402789</basicUdiDi>
    <tradeName>High-sensitivity Cardiac Troponin I (hs-cTnI) Quantitative Test (Quantum Dot Fluorescence Immunochromatography)</tradeName>
    <deviceName>High-sensitivity Cardiac Troponin I (hs-cTnI) Quantitative Test (Quantum Dot Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:02.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698402567</udiDi>
    <basicUdiDi>B-06977698402567</basicUdiDi>
    <tradeName>Myoglobin (Myo) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin (Myo) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:55.633Z</lastUpdated>
  </row>
</eudamedExport>