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<eudamedExport entity="devices">
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    <udiDi>04260430940529</udiDi>
    <basicUdiDi>426043094HMCACCESSORIESG5</basicUdiDi>
    <tradeName>MC Hanger (Single Use)</tradeName>
    <deviceName>Hepalbin-MaxiCycler Zubehör</deviceName>
    <manufacturerName>Albutec GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009769</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80006-A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:59:18.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842289103764</udiDi>
    <basicUdiDi>08422891FLUIDWARMERZQ</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>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FW-300-WW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T11:58:28.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200275</udiDi>
    <basicUdiDi>7332414VA0000232T</basicUdiDi>
    <tradeName>U9000 Plus Ultrafilter</tradeName>
    <deviceName>U9000 Plus Ultrafilter</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>955825A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:34:01.146Z</lastUpdated>
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  <row>
    <udiDi>00884908165692</udiDi>
    <basicUdiDi>00884908105MQ</basicUdiDi>
    <tradeName>Tesio and Chronic Twinline Repair Kit</tradeName>
    <deviceName>Tesio and Chronic Twinline Repair Kits</deviceName>
    <manufacturerName>Medical Components, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008230</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NITSL-EXT-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:39:50.760Z</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>07332414200282</udiDi>
    <basicUdiDi>7332414VA0000232T</basicUdiDi>
    <tradeName>U9000 Plus Ultrafilter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>955826A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:34:49.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059591520390</udiDi>
    <basicUdiDi>805959152ACX</basicUdiDi>
    <tradeName>BLU ARMLET - DISPOSITIVO PREMIFISTOLA MONOUSO</tradeName>
    <deviceName>BLU ARMLET</deviceName>
    <manufacturerName>D.R.M. S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000027115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLU ARMLET</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:28:50.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053879801423</udiDi>
    <basicUdiDi>805387980HC0039Z</basicUdiDi>
    <tradeName>SOFTPAC 130</tradeName>
    <deviceName>Connectors</deviceName>
    <manufacturerName>GVS S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028147</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1401304014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:54:51.238Z</lastUpdated>
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  <row>
    <udiDi>08053879801263</udiDi>
    <basicUdiDi>805387980WB008F9</basicUdiDi>
    <tradeName>AQUASAFE</tradeName>
    <deviceName>Waste bags</deviceName>
    <manufacturerName>GVS S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028147</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1500074406</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:54:46.447Z</lastUpdated>
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  <row>
    <udiDi>18052705960003</udiDi>
    <basicUdiDi>805270596AC16525</basicUdiDi>
    <tradeName>18052705960003</tradeName>
    <deviceName>Pinza premifistola</deviceName>
    <manufacturerName>SA.GE srl</manufacturerName>
    <manufacturerSrn>IT-MF-000030827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC 165 V DA 25 PZ SFUSI</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:37:00.321Z</lastUpdated>
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  <row>
    <udiDi>08033718001757</udiDi>
    <basicUdiDi>8033718HC003LF</basicUdiDi>
    <tradeName>SOFTPAC 130</tradeName>
    <deviceName>SOFTPAC Connectors</deviceName>
    <manufacturerName>Haemotronic S. p. A</manufacturerName>
    <manufacturerSrn>IT-MF-000029734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9080</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1401304014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:11:16.742Z</lastUpdated>
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</eudamedExport>