<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M535NX13480</udiDi>
    <basicUdiDi>B-M535NX13480</basicUdiDi>
    <tradeName>NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT</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>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX1348</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:53.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535NX10003A0</udiDi>
    <basicUdiDi>B-M535NX10003A0</basicUdiDi>
    <tradeName>NXSTAGE SYSTEM ONE</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>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NX1000-3-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:51.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535NX100010B0</udiDi>
    <basicUdiDi>B-M535NX100010B0</basicUdiDi>
    <tradeName>VersiHD</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>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX1000-10-B</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:50.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535NX06420</udiDi>
    <basicUdiDi>B-M535NX06420</basicUdiDi>
    <tradeName>NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT</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>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX0642</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:49.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FWS3090</udiDi>
    <basicUdiDi>B-M535FWS3090</basicUdiDi>
    <tradeName>EXPRESS FLUID WARMER DISPOSABLE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWS-309</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:46.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FWS3080</udiDi>
    <basicUdiDi>B-M535FWS3080</basicUdiDi>
    <tradeName>EXPRESS FLUID WARMER DISPOSABLE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWS-308</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:45.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FWS3050</udiDi>
    <basicUdiDi>B-M535FWS3050</basicUdiDi>
    <tradeName>EXPRESS FLUID WARMER DISPOSABLE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWS-305</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:44.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FWS3040</udiDi>
    <basicUdiDi>B-M535FWS3040</basicUdiDi>
    <tradeName>EXPRESS FLUID WARMER DISPOSABLE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWS-304</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:42.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FWS209B0</udiDi>
    <basicUdiDi>B-M535FWS209B0</basicUdiDi>
    <tradeName>COMFORTMATE FLUID WARMER DISPOSABLE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWS-209-B</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:39.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FWS206B0</udiDi>
    <basicUdiDi>B-M535FWS206B0</basicUdiDi>
    <tradeName>COMFORTMATE FLUID WARMER DISPOSABLE</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FWS-206-B</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:38.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FW300WW0</udiDi>
    <basicUdiDi>B-M535FW300WW0</basicUdiDi>
    <tradeName>NxStage Express Fluid Warmer</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FW-300-WW</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:37.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FW300A0</udiDi>
    <basicUdiDi>B-M535FW300A0</basicUdiDi>
    <tradeName>EXPRESS FLUID WARMER</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FW-300-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:35.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FW3000</udiDi>
    <basicUdiDi>B-M535FW3000</basicUdiDi>
    <tradeName>EXPRESS FLUID WARMER</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FW-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:33.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535FW2000</udiDi>
    <basicUdiDi>B-M535FW2000</basicUdiDi>
    <tradeName>COMFORTMATE FLUID WARMER</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FW-200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:30.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DLC1230JKPT</udiDi>
    <basicUdiDi>B-DLC1230JKPT</basicUdiDi>
    <tradeName>Adhe-FLOW® DUO  Kit cathéter d’hémodialyse fémorale double lumières  FR12  L.: 30cm</tradeName>
    <deviceName>Adhe-FLOW® DUO  Kit cathéter d’hémodialyse fémorale double lumières  FR12  L.: 30cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLC1230JK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:51.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DLC1226JKQJ</udiDi>
    <basicUdiDi>B-DLC1226JKQJ</basicUdiDi>
    <tradeName>Adhe-FLOW® DUO  Kit cathéter d’hémodialyse fémorale double lumières  FR12 L.: 26cm</tradeName>
    <deviceName>Adhe-FLOW® DUO Kit cathéter d’hémodialyse fémorale double lumières FR12 L.:26cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLC1226JK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:49.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DLC1222JKPW</udiDi>
    <basicUdiDi>B-DLC1222JKPW</basicUdiDi>
    <tradeName>Adhe-FLOW® DUO  Kit cathéter d’hémodialyse fémorale double lumières   FR12 L.: 22cm</tradeName>
    <deviceName>Adhe-FLOW® DUO Kit cathéter d’hémodialyse fémorale double lumières FR12 L.:22cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLC1222JK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:49.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DLC1220JKPL</udiDi>
    <basicUdiDi>B-DLC1220JKPL</basicUdiDi>
    <tradeName>Adhe-FLOW® DUO  Kit cathéter d’hémodialyse fémorale double lumières FR12 L.: 20cm</tradeName>
    <deviceName>Adhe-FLOW® DUO  Kit cathéter d’hémodialyse fémorale double lumières FR12 L.: 20cm</deviceName>
    <manufacturerName>Adhe-Els SA.</manufacturerName>
    <manufacturerSrn>TN-MF-000011757</manufacturerSrn>
    <authorisedRepresentativeName>ADHE-ELS FRANCE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001654</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900299</emdnCode>
    <emdnDescription>VASCULAR ACCESS DEVICES (ONLY FOR HAEMODIALYSIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLC1220JK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:47.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077485494</udiDi>
    <basicUdiDi>B-86989077485494</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Hemodialysis catheter kit</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - HCT10100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:15:24.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077485326</udiDi>
    <basicUdiDi>B-86989077485326</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Hemodialysis catheter kit</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F900201</emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - HCT10099</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:15:23.923Z</lastUpdated>
  </row>
</eudamedExport>