<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M535SAK3050</udiDi>
    <basicUdiDi>B-M535SAK3050</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-305</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:44.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK304A0</udiDi>
    <basicUdiDi>B-M535SAK304A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-304-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:44.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK3040</udiDi>
    <basicUdiDi>B-M535SAK3040</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-304</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:37.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK303A0</udiDi>
    <basicUdiDi>B-M535SAK303A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-303-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:35.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK3030</udiDi>
    <basicUdiDi>B-M535SAK3030</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-303</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:33.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK302A0</udiDi>
    <basicUdiDi>B-M535SAK302A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-302-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:31.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK3020</udiDi>
    <basicUdiDi>B-M535SAK3020</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-302</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:25.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK301A0</udiDi>
    <basicUdiDi>B-M535SAK301A0</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-301-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:23.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK3010</udiDi>
    <basicUdiDi>B-M535SAK3010</basicUdiDi>
    <tradeName>Dialysate Sack (SAK) with Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NxStage Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026832</manufacturerSrn>
    <authorisedRepresentativeName>Fresenius Medical Care Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009269</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAK-301</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:22.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8699459939980QL</udiDi>
    <basicUdiDi>B-8699459939980QL</basicUdiDi>
    <tradeName>FARMAKON BASIC CONCENTRATE HEMODIALYSIS SOLUTION</tradeName>
    <deviceName>FARMAKON BASIC CONCENTRATE HEMODIALYSIS SOLUTION</deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>998</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:25:42.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8699459939973QP</udiDi>
    <basicUdiDi>B-8699459939973QP</basicUdiDi>
    <tradeName>FARMAKON B35 10LT BASIC CONCENTRATE HEMODIALYSIS SOLUTION</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:25:41.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8699459939966QS</udiDi>
    <basicUdiDi>B-8699459939966QS</basicUdiDi>
    <tradeName>FARMAKON B36 5LT BASIC CONCENTRATE HEMODIALYSIS SOLUTION</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>996</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:25:37.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8699459939959QV</udiDi>
    <basicUdiDi>B-8699459939959QV</basicUdiDi>
    <tradeName>FARMAKON B36 6LT BASIC CONCENTRATE HEMODIALYSIS SOLUTION</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:25:35.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8699459935142N8</udiDi>
    <basicUdiDi>B-8699459935142N8</basicUdiDi>
    <tradeName>FARMAKON B35 5LT BASIC CONCENTRATE HEMODIALYSIS SOLUTION</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:05:59.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463794017</udiDi>
    <basicUdiDi>B-08683463794017</basicUdiDi>
    <tradeName>RENASOL</tradeName>
    <deviceName>RENASOL BB-8.4 Basic Bicarbonate Concentrate Hemodialysis Solution 10L</deviceName>
    <manufacturerName>Fresenius Medikal Tıbbi Cihaz ve Sarf Malzemeleri Üretim A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025101</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD.10.014</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:05:38.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463794000</udiDi>
    <basicUdiDi>B-08683463794000</basicUdiDi>
    <tradeName>RENASOL</tradeName>
    <deviceName>RENASOL BB-8.4 Basic Bicarbonate Concentrate Hemodialysis Solution 6L</deviceName>
    <manufacturerName>Fresenius Medikal Tıbbi Cihaz ve Sarf Malzemeleri Üretim A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025101</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD.10.013</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:05:37.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699459939942</udiDi>
    <basicUdiDi>8699459939980QL</basicUdiDi>
    <tradeName>FARMAKON B36 10LT</tradeName>
    <deviceName>FARMAKON BASIC CONCENTRATE HEMODIALYSIS SOLUTION</deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>994</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:14:26.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699459939997</udiDi>
    <basicUdiDi>8699459939980QL</basicUdiDi>
    <tradeName>FARMAKON B35 5LT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:14.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699459939966</udiDi>
    <basicUdiDi>8699459939980QL</basicUdiDi>
    <tradeName>FARMAKON B36 5LT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>996</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:55.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699459939959</udiDi>
    <basicUdiDi>8699459939980QL</basicUdiDi>
    <tradeName>FARMAKON B36 6LT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KON-MED Sağlık İnşaat Turizm ve Eğitim Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000020885</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040202</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, LIQUID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:45.986Z</lastUpdated>
  </row>
</eudamedExport>