<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M535SAK3070</udiDi>
    <basicUdiDi>B-M535SAK3070</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-307</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:49.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK306A0</udiDi>
    <basicUdiDi>B-M535SAK306A0</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-306-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:48.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK3060</udiDi>
    <basicUdiDi>B-M535SAK3060</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-306</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:44.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535SAK305A0</udiDi>
    <basicUdiDi>B-M535SAK305A0</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-A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:44.627Z</lastUpdated>
  </row>
  <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-DEMF00000500215664T</udiDi>
    <basicUdiDi>B-DEMF00000500215664T</basicUdiDi>
    <tradeName>DiaCart</tradeName>
    <deviceName>DiaCart 650 g OP/F/C</deviceName>
    <manufacturerName>Serumwerk Bernburg Vertriebs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1566</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:33.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF00000500215654R</udiDi>
    <basicUdiDi>B-DEMF00000500215654R</basicUdiDi>
    <tradeName>DiaCart</tradeName>
    <deviceName>DiaCart 650 g CP</deviceName>
    <manufacturerName>Serumwerk Bernburg Vertriebs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1565</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:32.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF00000500215624K</udiDi>
    <basicUdiDi>B-DEMF00000500215624K</basicUdiDi>
    <tradeName>DiaCart</tradeName>
    <deviceName>DiaCart 750 g OP/F/C</deviceName>
    <manufacturerName>Serumwerk Bernburg Vertriebs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1562</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:31.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF00000500215604F</udiDi>
    <basicUdiDi>B-DEMF00000500215604F</basicUdiDi>
    <tradeName>DiaCart</tradeName>
    <deviceName>DiaCart 750 g CP</deviceName>
    <manufacturerName>Serumwerk Bernburg Vertriebs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1560</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:27.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000005002152043</udiDi>
    <basicUdiDi>B-DEMF000005002152043</basicUdiDi>
    <tradeName>DiaCart</tradeName>
    <deviceName>DiaCart 720 g OP/F/C</deviceName>
    <manufacturerName>Serumwerk Bernburg Vertriebs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:27.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF00000500215184G</udiDi>
    <basicUdiDi>B-DEMF00000500215184G</basicUdiDi>
    <tradeName>DiaCart</tradeName>
    <deviceName>DiaCart 760 g OP/F-C</deviceName>
    <manufacturerName>Serumwerk Bernburg Vertriebs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1518</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:26.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF00000500215154A</udiDi>
    <basicUdiDi>B-DEMF00000500215154A</basicUdiDi>
    <tradeName>DiaCart</tradeName>
    <deviceName>DiaCart 720 g OP/F-B</deviceName>
    <manufacturerName>Serumwerk Bernburg Vertriebs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:25.548Z</lastUpdated>
  </row>
</eudamedExport>