<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974643920145</udiDi>
    <basicUdiDi>697464392METH01RW</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)</deviceName>
    <manufacturerName>ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000015645</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EH001C-200 200 tests/kit</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:13:56.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974643920138</udiDi>
    <basicUdiDi>697464392METH01RW</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)</deviceName>
    <manufacturerName>ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000015645</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EH001C-50 50 tests/kit</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:13:54.945Z</lastUpdated>
  </row>
</eudamedExport>