<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800109700038</udiDi>
    <basicUdiDi>880010970003A7</basicUdiDi>
    <tradeName>08800109700038</tradeName>
    <deviceName>Erythrocyte Sedimentation Rate Analyzer</deviceName>
    <manufacturerName>SHINWHA MEDI CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000044090</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>easy M30</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:05.766Z</lastUpdated>
  </row>
</eudamedExport>