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<eudamedExport entity="devices">
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    <basicUdiDi>B-M535NX200011EU0</basicUdiDi>
    <tradeName>PUREFLOW SL</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>NX2000-11-EU</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:15.763Z</lastUpdated>
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  <row>
    <udiDi>M535NX13730</udiDi>
    <basicUdiDi>B-M535NX13730</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>NX1373</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:11.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535NX2000100</udiDi>
    <basicUdiDi>B-M535NX2000100</basicUdiDi>
    <tradeName>PUREFLOW SL</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>NX2000-10</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:10.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535NX200010</udiDi>
    <basicUdiDi>B-M535NX200010</basicUdiDi>
    <tradeName>PUREFLOW SL</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>NX2000-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:57:09.511Z</lastUpdated>
  </row>
  <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>07640137442767</udiDi>
    <basicUdiDi>B-07640137442767</basicUdiDi>
    <tradeName>DIMI</tradeName>
    <deviceName>DIMI</deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DM-850-00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:40.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137442743</udiDi>
    <basicUdiDi>B-07640137442743</basicUdiDi>
    <tradeName>IN300</tradeName>
    <deviceName>IN300</deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-300-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:39.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137442156</udiDi>
    <basicUdiDi>B-07640137442156</basicUdiDi>
    <tradeName>HF440</tradeName>
    <deviceName>HF440</deviceName>
    <manufacturerName>INFOMED SA</manufacturerName>
    <manufacturerSrn>CH-MF-000021686</manufacturerSrn>
    <authorisedRepresentativeName>INFOMED SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HF-440-05</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:42:22.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>04054839078217</udiDi>
    <basicUdiDi>B-04054839078217</basicUdiDi>
    <tradeName>Dualex Transducer Protector</tradeName>
    <deviceName>Dualex Transducer Protector</deviceName>
    <manufacturerName>Merck Millipore Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000003997</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLGVS25XS</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:19.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>04054839076572</udiDi>
    <basicUdiDi>B-04054839076572</basicUdiDi>
    <tradeName>Dualex Ultra Transducer Protector</tradeName>
    <deviceName>Dualex Ultra Transducer Protector</deviceName>
    <manufacturerName>Merck Millipore Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000003997</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLGVS25US</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:24:20.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>04054839076565</udiDi>
    <basicUdiDi>B-04054839076565</basicUdiDi>
    <tradeName>Dualex Plus Transducer Protector</tradeName>
    <deviceName>Dualex Plus Transducer Protector</deviceName>
    <manufacturerName>Merck Millipore Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000003997</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLGVS25PS</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:24:16.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>04053252666612</udiDi>
    <basicUdiDi>B-04053252666612</basicUdiDi>
    <tradeName>Dualex Transducer Protector</tradeName>
    <deviceName>Dualex Transducer Protector</deviceName>
    <manufacturerName>Merck Millipore Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000003997</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLTP025BM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:23:24.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848340018237</udiDi>
    <basicUdiDi>B-00848340018237</basicUdiDi>
    <tradeName>00848340018237</tradeName>
    <deviceName>Sterile Ura Drain Bag</deviceName>
    <manufacturerName>Advance Medical Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009790</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KYRA8411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:25:09.201Z</lastUpdated>
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    <udiDi>00848340018213</udiDi>
    <basicUdiDi>B-00848340018213</basicUdiDi>
    <tradeName>00848340018213</tradeName>
    <deviceName>STERILE URO DRAIN BAG</deviceName>
    <manufacturerName>Advance Medical Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009790</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KTEK8411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:25:07.595Z</lastUpdated>
  </row>
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    <udiDi>00848340010774</udiDi>
    <basicUdiDi>B-00848340010774</basicUdiDi>
    <tradeName>00848340010774</tradeName>
    <deviceName>Polyethylene Easy Catcher</deviceName>
    <manufacturerName>Advance Medical Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009790</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-EC51-UK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:24:44.383Z</lastUpdated>
  </row>
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    <udiDi>00848340012952</udiDi>
    <basicUdiDi>B-00848340012952</basicUdiDi>
    <tradeName>00848340012952</tradeName>
    <deviceName>Polyethylene Ura Drain Bag</deviceName>
    <manufacturerName>Advance Medical Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009790</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X100-3000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:24:43.585Z</lastUpdated>
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    <udiDi>00848340010767</udiDi>
    <basicUdiDi>B-00848340010767</basicUdiDi>
    <tradeName>00848340010767</tradeName>
    <deviceName>Polyethylene Easy Catcher</deviceName>
    <manufacturerName>Advance Medical Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009790</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-EC51-JP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:24:28.333Z</lastUpdated>
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