<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06975424221833</udiDi>
    <basicUdiDi>B-06975424221833</basicUdiDi>
    <tradeName>Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100504</emdnCode>
    <emdnDescription>APLS SCREENING (OR ANTI-CARDIOLIPIN / ANTI-B2-GLYCOPROTEIN COMBITEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:26:04.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225510</udiDi>
    <basicUdiDi>B-06975424225510</basicUdiDi>
    <tradeName>Anti-Cardiolipin IgG/IgM Assay Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-Cardiolipin IgG/IgM Assay Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100504</emdnCode>
    <emdnDescription>APLS SCREENING (OR ANTI-CARDIOLIPIN / ANTI-B2-GLYCOPROTEIN COMBITEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL212901C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:03.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223790</udiDi>
    <basicUdiDi>B-06975424223790</basicUdiDi>
    <tradeName>06975424223790</tradeName>
    <deviceName>Anti-Cardiolipin IgG/IgM Assay Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100504</emdnCode>
    <emdnDescription>APLS SCREENING (OR ANTI-CARDIOLIPIN / ANTI-B2-GLYCOPROTEIN COMBITEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL212905</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:12.162Z</lastUpdated>
  </row>
</eudamedExport>