<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06978261340071</udiDi>
    <basicUdiDi>697826134YLCDEKWW</basicUdiDi>
    <tradeName>06978261340071</tradeName>
    <deviceName>YALEPIC® Cell-Free DNA Extraction Kit（Magbead)</deviceName>
    <manufacturerName>YALI BIOTECH</manufacturerName>
    <manufacturerSrn>CN-MF-000046226</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Non-prepackaged 96 tests/Box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:24:06.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978261340040</udiDi>
    <basicUdiDi>697826134YLUCDSTET</basicUdiDi>
    <tradeName>06978261340040</tradeName>
    <deviceName>YALEPIC® Urine Cell-Free DNA Storage Tube</deviceName>
    <manufacturerName>YALI BIOTECH</manufacturerName>
    <manufacturerSrn>CN-MF-000046226</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010202</emdnCode>
    <emdnDescription>URINE COLLECTION, TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 ml</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:24:05.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978261340002</udiDi>
    <basicUdiDi>697826134YLVBCT38</basicUdiDi>
    <tradeName>06978261340002</tradeName>
    <deviceName>YALEPIC® Vacuette Blood Collection Tube (Cell-Free DNA Storage Tube)</deviceName>
    <manufacturerName>YALI BIOTECH</manufacturerName>
    <manufacturerSrn>CN-MF-000046226</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Glass Tube 5 ml</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:24:03.949Z</lastUpdated>
  </row>
</eudamedExport>