<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987671011282</udiDi>
    <basicUdiDi>B-04987671011282</basicUdiDi>
    <tradeName>FDY-210GW</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-210GW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:31.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671011275</udiDi>
    <basicUdiDi>B-04987671011275</basicUdiDi>
    <tradeName>FDY-180GW</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-180GW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:30.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671011268</udiDi>
    <basicUdiDi>B-04987671011268</basicUdiDi>
    <tradeName>FDY-150GW</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-150GW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:10:26.472Z</lastUpdated>
  </row>
  <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>
  <row>
    <udiDi>04987671600004</udiDi>
    <basicUdiDi>4987671HD-EqA2P</basicUdiDi>
    <tradeName>DBB-EXA</tradeName>
    <deviceName>Hemodialysis Equipment DBB-EXA</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMODIALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBB-EXA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:31.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671041616</udiDi>
    <basicUdiDi>B-04987671041616</basicUdiDi>
    <tradeName>HAEMODIALYSIS EQUIPMENT</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMODIALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DO-F371-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671041678</udiDi>
    <basicUdiDi>B-04987671041678</basicUdiDi>
    <tradeName>HAEMODIALYSIS EQUIPMENT</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMODIALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3313</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671200006</udiDi>
    <basicUdiDi>B-04987671200006</basicUdiDi>
    <tradeName>Blood Tubing Lines for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DO-F418-00</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671200013</udiDi>
    <basicUdiDi>B-04987671200013</basicUdiDi>
    <tradeName>Blood Tubing Lines for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DO-F418-00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671200020</udiDi>
    <basicUdiDi>B-04987671200020</basicUdiDi>
    <tradeName>Blood Tubing Lines for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DO-F418-00</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:20.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671200037</udiDi>
    <basicUdiDi>B-04987671200037</basicUdiDi>
    <tradeName>Blood Tubing Lines for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DO-F418-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:20.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671200044</udiDi>
    <basicUdiDi>B-04987671200044</basicUdiDi>
    <tradeName>Blood Tubing Lines for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DO-F418-00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:20.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987671200051</udiDi>
    <basicUdiDi>B-04987671200051</basicUdiDi>
    <tradeName>Blood Tubing Lines for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIKKISO CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000019276</manufacturerSrn>
    <authorisedRepresentativeName>NIKKISO Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000042794</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DO-F418-00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:20.944Z</lastUpdated>
  </row>
</eudamedExport>