<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987671011251</udiDi>
    <basicUdiDi>B-04987671011251</basicUdiDi>
    <tradeName>FDY-120GW</tradeName>
    <deviceName>Hemodialyzer FD series</deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDY-120GW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:25.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671011244</udiDi>
    <basicUdiDi>B-04987671011244</basicUdiDi>
    <tradeName>FDY-100GW</tradeName>
    <deviceName>Hemodialyzer FD series</deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDY-100GW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:24.867Z</lastUpdated>
  </row>
</eudamedExport>