<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4106201GX</udiDi>
    <basicUdiDi>B-IM4106201GX</basicUdiDi>
    <tradeName>D-IM4106201GX</tradeName>
    <deviceName>Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4106201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:46.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4105201GQ</udiDi>
    <basicUdiDi>B-IM4105201GQ</basicUdiDi>
    <tradeName>D-IM4105201GQ</tradeName>
    <deviceName>Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4105201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:41.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4104201GH</udiDi>
    <basicUdiDi>B-IM4104201GH</basicUdiDi>
    <tradeName>D-IM4104201GH</tradeName>
    <deviceName>Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4104201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:35.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDCKM-402aWW</udiDi>
    <basicUdiDi>B-GDCKM-402aWW</basicUdiDi>
    <tradeName>CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCKM-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:33.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDCKM-402aHGUQ</udiDi>
    <basicUdiDi>B-GDCKM-402aHGUQ</basicUdiDi>
    <tradeName>CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>CK-MB 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCKM-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:31.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDCKM-302aWP</udiDi>
    <basicUdiDi>B-GDCKM-302aWP</basicUdiDi>
    <tradeName>One Step CK-MB Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>One Step CK-MB Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCKM-302a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:31.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDCKM-302aHGUB</udiDi>
    <basicUdiDi>B-GDCKM-302aHGUB</basicUdiDi>
    <tradeName>One Step CK-MB Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>One Step CK-MB 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCKM-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:29.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-MB-D06aL4</udiDi>
    <basicUdiDi>B-CK-MB-D06aL4</basicUdiDi>
    <tradeName>CK-MB Test Kit FIA</tradeName>
    <deviceName>CK-MB Test Kit FIA</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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-MB-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:38.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-CT-A66SR</udiDi>
    <basicUdiDi>B-ABT-CT-A66SR</basicUdiDi>
    <tradeName>Accu-Tell® CK-MB Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® CK-MB Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-A66</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:19:48.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763426</udiDi>
    <basicUdiDi>B-15065023763426</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>CK-MB 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:14.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250292</udiDi>
    <basicUdiDi>B-08683548250292</basicUdiDi>
    <tradeName>RapidFor™CK-MB (FIA)</tradeName>
    <deviceName>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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:37.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415946</udiDi>
    <basicUdiDi>B-06978896415946</basicUdiDi>
    <tradeName>06978896415946</tradeName>
    <deviceName>Creatine Kinase Isoenzymes (CK-MB) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-CK-MB-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:34.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415939</udiDi>
    <basicUdiDi>B-06978896415939</basicUdiDi>
    <tradeName>06978896415939</tradeName>
    <deviceName>Creatine Kinase Isoenzymes (CK-MB) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-CK-MB-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:31.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903346228</udiDi>
    <basicUdiDi>B-06977903346228</basicUdiDi>
    <tradeName>06977903346228</tradeName>
    <deviceName>CK-MB 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS120703C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:34.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903346211</udiDi>
    <basicUdiDi>B-06977903346211</basicUdiDi>
    <tradeName>06977903346211</tradeName>
    <deviceName>CK-MB 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS120703C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:33.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194142103</udiDi>
    <basicUdiDi>B-06977194142103</basicUdiDi>
    <tradeName>06977194142103</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0513003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:13:40.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194142097</udiDi>
    <basicUdiDi>B-06977194142097</basicUdiDi>
    <tradeName>06977194142097</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0513002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:13:40.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194142080</udiDi>
    <basicUdiDi>B-06977194142080</basicUdiDi>
    <tradeName>06977194142080</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0513001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:13:36.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141700</udiDi>
    <basicUdiDi>B-06977194141700</basicUdiDi>
    <tradeName>06977194141700</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0201801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:23.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374751043</udiDi>
    <basicUdiDi>B-06976374751043</basicUdiDi>
    <tradeName>Creatine kinase isoenzyme MB(CK-MB) Test Kit (Fluorescence immunochromatography method)</tradeName>
    <deviceName>Creatine kinase isoenzyme MB(CK-MB) Test Kit (Fluorescence immunochromatography method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR051-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:42:33.220Z</lastUpdated>
  </row>
</eudamedExport>