<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06950617416326</udiDi>
    <basicUdiDi>69506174IM440010CP</basicUdiDi>
    <tradeName>06950617416326</tradeName>
    <deviceName>HAV IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:51.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617416265</udiDi>
    <basicUdiDi>69506174IM440010CP</basicUdiDi>
    <tradeName>06950617416265</tradeName>
    <deviceName>HAV IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:50.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617410850</udiDi>
    <basicUdiDi>69506174IM440010CP</basicUdiDi>
    <tradeName>06950617410850</tradeName>
    <deviceName>HAV IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4405010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:04.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505516</udiDi>
    <basicUdiDi>B-06947145505516</basicUdiDi>
    <tradeName>MAGLUMI HAV IgM (CLIA)</tradeName>
    <deviceName>HAV IgM (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130210008M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:18:03.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505493</udiDi>
    <basicUdiDi>B-06947145505493</basicUdiDi>
    <tradeName>MAGLUMI Anti-HAV (CLIA)</tradeName>
    <deviceName>Anti-HAV (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130210007M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:56.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370063</udiDi>
    <basicUdiDi>B-04262353370063</basicUdiDi>
    <tradeName>PoET HAV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2D-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:20.591Z</lastUpdated>
  </row>
</eudamedExport>