<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4403151HT</udiDi>
    <basicUdiDi>B-IM4403151HT</basicUdiDi>
    <tradeName>D-IM4403151HT</tradeName>
    <deviceName>MYO (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:15.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402151HL</udiDi>
    <basicUdiDi>B-IM4402151HL</basicUdiDi>
    <tradeName>D-IM4402151HL</tradeName>
    <deviceName>MYO (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:50.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4401151HD</udiDi>
    <basicUdiDi>B-IM4401151HD</basicUdiDi>
    <tradeName>D-IM4401151HD</tradeName>
    <deviceName>MYO (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4401151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:15:51.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GDMYO-402aD7</udiDi>
    <basicUdiDi>B-GDMYO-402aD7</basicUdiDi>
    <tradeName>Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDMYO-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:44.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDMYO-402aHGFY</udiDi>
    <basicUdiDi>B-FDMYO-402aHGFY</basicUdiDi>
    <tradeName>Myo Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDMYO-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:07.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDMYO-402aCA</udiDi>
    <basicUdiDi>B-FDMYO-402aCA</basicUdiDi>
    <tradeName>Myo Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>Myo Quantitative Test Kit (Time-Resolved FIA)</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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDMYO-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:06.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FA0011YV</udiDi>
    <basicUdiDi>B-FA0011YV</basicUdiDi>
    <tradeName>Myoglobin (Myo) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Myoglobin (Myo) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52027003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:36.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01747L</udiDi>
    <basicUdiDi>B-DT01747L</basicUdiDi>
    <tradeName>CK-MB/hs-cTnI/Myo</tradeName>
    <deviceName>CK-MB/hs-cTnI/Myo</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0174</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:34.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01737J</udiDi>
    <basicUdiDi>B-DT01737J</basicUdiDi>
    <tradeName>CK-MB/hs-cTnI/Myo</tradeName>
    <deviceName>CK-MB/hs-cTnI/Myo</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0173</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:32.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00757H</udiDi>
    <basicUdiDi>B-DT00757H</basicUdiDi>
    <tradeName>Unicorn-Myoglobin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0075</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:15:33.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00667G</udiDi>
    <basicUdiDi>B-DT00667G</basicUdiDi>
    <tradeName>Unicorn-CK-MB/hs-cTnI/Myo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 Tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:15:12.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00116P</udiDi>
    <basicUdiDi>B-DT00116P</basicUdiDi>
    <tradeName>Unicorn-Myoglobin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:20.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00026N</udiDi>
    <basicUdiDi>B-DT00026N</basicUdiDi>
    <tradeName>Unicorn-CK-MB/hs-cTnI/Myo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:07.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC79003FN</udiDi>
    <basicUdiDi>B-DC79003FN</basicUdiDi>
    <tradeName>iStar-Myoglobin</tradeName>
    <deviceName>iStar-Myoglobin</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC79003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:11.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76133FF</udiDi>
    <basicUdiDi>B-DC76133FF</basicUdiDi>
    <tradeName>iStar-Myoglobin Ⅱ</tradeName>
    <deviceName>iStar-Myoglobin Ⅱ</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76133</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:49.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76132FD</udiDi>
    <basicUdiDi>B-DC76132FD</basicUdiDi>
    <tradeName>iStar-Myoglobin Ⅱ</tradeName>
    <deviceName>iStar-Myoglobin Ⅱ</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76132</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:48.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76131FB</udiDi>
    <basicUdiDi>B-DC76131FB</basicUdiDi>
    <tradeName>iStar-Myoglobin Ⅱ</tradeName>
    <deviceName>iStar-Myoglobin Ⅱ</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76131</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:45.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76101F2</udiDi>
    <basicUdiDi>B-DC76101F2</basicUdiDi>
    <tradeName>iStar-Myoglobin Ⅱ</tradeName>
    <deviceName>iStar-Myoglobin Ⅱ</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:42.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7J03EK</udiDi>
    <basicUdiDi>B-7J03EK</basicUdiDi>
    <tradeName>Myoglobin assay (CLIA)</tradeName>
    <deviceName>Myoglobin assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7J03V1-B-EU, 7J03U1-B-EU, 7J03P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:24.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346229</udiDi>
    <basicUdiDi>B-20850076346229</basicUdiDi>
    <tradeName>Myoglobin Test Kit (CLIA)</tradeName>
    <deviceName>Myoglobin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</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>CDMYO-401a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:02:59.830Z</lastUpdated>
  </row>
</eudamedExport>