<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH01011634Y</udiDi>
    <basicUdiDi>B-ECH01011634Y</basicUdiDi>
    <tradeName>D-ECH01011634Y</tradeName>
    <deviceName>Lipoprotein (a)(LP(a))</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>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:08.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975838802154</udiDi>
    <basicUdiDi>B-06975838802154</basicUdiDi>
    <tradeName>06975838802154</tradeName>
    <deviceName>Lipoprotein (a) Assay Kit</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010220</emdnCode>
    <emdnDescription>LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:14:04.809Z</lastUpdated>
  </row>
</eudamedExport>