<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07332414120306</udiDi>
    <basicUdiDi>73324140000000000000119VJ</basicUdiDi>
    <tradeName>Prismocitrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bieffe Medital S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019172</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115655</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:47:34.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414126896</udiDi>
    <basicUdiDi>73324140000000000000119VJ</basicUdiDi>
    <tradeName>Prismocitrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bieffe Medital S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019172</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>955808</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:46:49.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414123147</udiDi>
    <basicUdiDi>73324140000000000000119VJ</basicUdiDi>
    <tradeName>Prismocitrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bieffe Medital S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019172</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>955427</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:46:42.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414125028</udiDi>
    <basicUdiDi>73324140000000000000119VJ</basicUdiDi>
    <tradeName>Prismocitrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bieffe Medital S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019172</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>955659</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:46:40.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>05213013180019</udiDi>
    <basicUdiDi>521301318DOCTICARTRV</basicUdiDi>
    <tradeName>DOCTICART 650g</tradeName>
    <deviceName>BICASOL / DOCTICART / BICASOL CA / DOCTICART CA</deviceName>
    <manufacturerName>DOCTUM PHARMACEUTICAL SA K.GIOKARIS &amp; Co</manufacturerName>
    <manufacturerSrn>GR-MF-000015973</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.104005</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:48:38.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082708718</udiDi>
    <basicUdiDi>6948082701183AA</basicUdiDi>
    <tradeName>DORA Tubing Sets for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-112G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:27.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082708732</udiDi>
    <basicUdiDi>6948082701183AA</basicUdiDi>
    <tradeName>DORA Tubing Sets for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-114G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:27.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082708756</udiDi>
    <basicUdiDi>6948082701183AA</basicUdiDi>
    <tradeName>DORA Tubing Sets for Hemodialysis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-116G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:27.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>05213013181016</udiDi>
    <basicUdiDi>521301318DOCTICARTRV</basicUdiDi>
    <tradeName>BICASOL CA 650g</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DOCTUM PHARMACEUTICAL SA K.GIOKARIS &amp; Co</manufacturerName>
    <manufacturerSrn>GR-MF-000015973</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.104070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:10.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>05213013180026</udiDi>
    <basicUdiDi>521301318DOCTICARTRV</basicUdiDi>
    <tradeName>DOCTICART 720g</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DOCTUM PHARMACEUTICAL SA K.GIOKARIS &amp; Co</manufacturerName>
    <manufacturerSrn>GR-MF-000015973</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.104006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:10.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>05213013180071</udiDi>
    <basicUdiDi>521301318DOCTICARTRV</basicUdiDi>
    <tradeName>DOCTICART 720g (BELLCO)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DOCTUM PHARMACEUTICAL SA K.GIOKARIS &amp; Co</manufacturerName>
    <manufacturerSrn>GR-MF-000015973</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040201</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.104054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T19:46:09.808Z</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>00842289103689</udiDi>
    <basicUdiDi>08422891FLUIDDETECTSH</basicUdiDi>
    <tradeName>NxStage System One Cycler Base &amp; Fluid Detection Sensor</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>MDR 2017/745</legislation>
    <emdnCode>F9099</emdnCode>
    <emdnDescription>DIALYSIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX0642</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T11:58:27.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082703553</udiDi>
    <basicUdiDi>6948082703313AD</basicUdiDi>
    <tradeName>DORA Hollow Fiber Dialyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-21P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082703546</udiDi>
    <basicUdiDi>6948082703313AD</basicUdiDi>
    <tradeName>DORA Hollow Fiber Dialyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-19P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082703539</udiDi>
    <basicUdiDi>6948082703313AD</basicUdiDi>
    <tradeName>DORA Hollow Fiber Dialyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-17P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082703522</udiDi>
    <basicUdiDi>6948082703313AD</basicUdiDi>
    <tradeName>DORA Hollow Fiber Dialyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-15P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082703515</udiDi>
    <basicUdiDi>6948082703313AD</basicUdiDi>
    <tradeName>DORA Hollow Fiber Dialyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-13P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082703508</udiDi>
    <basicUdiDi>6948082703313AD</basicUdiDi>
    <tradeName>DORA Hollow Fiber Dialyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-12P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948082703492</udiDi>
    <basicUdiDi>6948082703313AD</basicUdiDi>
    <tradeName>DORA Hollow Fiber Dialyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-11P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:09.994Z</lastUpdated>
  </row>
</eudamedExport>