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<eudamedExport entity="devices">
  <row>
    <udiDi>04537693006843</udiDi>
    <basicUdiDi>4537693APSHE/001AX</basicUdiDi>
    <tradeName>APS</tradeName>
    <deviceName>ASAHI APS-HE SERIES HEMODIAFILTER</deviceName>
    <manufacturerName>Asahi Kasei Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000013951</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APS-22HE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:24:45.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>04537693003842</udiDi>
    <basicUdiDi>4537693REX-A/0017C</basicUdiDi>
    <tradeName>REXEED</tradeName>
    <deviceName>ASAHI REXEED-A SERIES DIALYZER</deviceName>
    <manufacturerName>Asahi Kasei Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000013951</manufacturerSrn>
    <authorisedRepresentativeName>Asahi Kasei Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012752</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REXEED-13A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:24:45.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535CAR172C0</udiDi>
    <basicUdiDi>B-M535CAR172C0</basicUdiDi>
    <tradeName>NXSTAGE CARTRIDGE EXPRESS</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>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-172-C</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:30.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>M535CAR170C0</udiDi>
    <basicUdiDi>B-M535CAR170C0</basicUdiDi>
    <tradeName>NXSTAGE CARTRIDGE EXPRESS</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>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-170-C</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:56:28.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>19349285000274</udiDi>
    <basicUdiDi>B-19349285000274</basicUdiDi>
    <tradeName>Aquamax</tradeName>
    <deviceName>Aquamax</deviceName>
    <manufacturerName>NorrDia Belgium bv</manufacturerName>
    <manufacturerSrn>BE-MF-000003701</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HF19</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:40.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>19349285000267</udiDi>
    <basicUdiDi>B-19349285000267</basicUdiDi>
    <tradeName>Aquamax</tradeName>
    <deviceName>Aquamax</deviceName>
    <manufacturerName>NorrDia Belgium bv</manufacturerName>
    <manufacturerSrn>BE-MF-000003701</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HF12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:38.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109191</udiDi>
    <basicUdiDi>B-09555793109191</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-24HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:01.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109184</udiDi>
    <basicUdiDi>B-09555793109184</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-22HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:14:00.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109177</udiDi>
    <basicUdiDi>B-09555793109177</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-20HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:56.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109160</udiDi>
    <basicUdiDi>B-09555793109160</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-18HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:55.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109153</udiDi>
    <basicUdiDi>B-09555793109153</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-16HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:54.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109146</udiDi>
    <basicUdiDi>B-09555793109146</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-14HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:39.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109078</udiDi>
    <basicUdiDi>B-09555793109078</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA21H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:30.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109061</udiDi>
    <basicUdiDi>B-09555793109061</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA19H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:26.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109054</udiDi>
    <basicUdiDi>B-09555793109054</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA17H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:25.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109047</udiDi>
    <basicUdiDi>B-09555793109047</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA15H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:25.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109030</udiDi>
    <basicUdiDi>B-09555793109030</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA13H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:24.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793102277</udiDi>
    <basicUdiDi>B-09555793102277</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-22HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:12:27.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793102239</udiDi>
    <basicUdiDi>B-09555793102239</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-14HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:12:25.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793102154</udiDi>
    <basicUdiDi>B-09555793102154</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzers</tradeName>
    <deviceName>Hollow Fiber Dialyzers</deviceName>
    <manufacturerName>Vital Healthcare Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000005704</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-24HF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:12:23.484Z</lastUpdated>
  </row>
</eudamedExport>