<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033772322072</udiDi>
    <basicUdiDi>803377232ULT-RWOSP</basicUdiDi>
    <tradeName>MEDiaPure™ DSU with Threaded Connections 1/2" - EO</tradeName>
    <deviceName>ULTRAFILTRATION DEVICES FOR PURIFIED WATER FOR REVERSE OSMOSIS</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01080201</emdnCode>
    <emdnDescription>ENDOTOXIN REMOVAL FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M03316</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:16.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321938</udiDi>
    <basicUdiDi>803377232DIA-602YA</basicUdiDi>
    <tradeName>Smartflux HFP.120  PUREMA®</tradeName>
    <deviceName>Dialyzers with KUF 18 -35 ml/h/mmHg</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M03537</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:13.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321860</udiDi>
    <basicUdiDi>803377232DIA-601Y8</basicUdiDi>
    <tradeName>Smartflux L1.6</tradeName>
    <deviceName>Dialyzers with KUF &lt; 18 ml/h/mmHg</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060103</emdnCode>
    <emdnDescription>DIALYSERS - UFC &lt; 18 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M03331</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:12.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772321808</udiDi>
    <basicUdiDi>803377232DIA-603YC</basicUdiDi>
    <tradeName>Smartflux H1.8</tradeName>
    <deviceName>Dialyzers with KUF &gt; 35 ml/h/mmHg</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>M03325</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:11.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772320009</udiDi>
    <basicUdiDi>803377232ULT-DIA-SETPC</basicUdiDi>
    <tradeName>HDF On-line - EO</tradeName>
    <deviceName>SET OF ULTRAFILTRATION FOR PURIFICATION OF DIALYSIS FLUID</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01080201</emdnCode>
    <emdnDescription>ENDOTOXIN REMOVAL FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M03162</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:04.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350146590006</udiDi>
    <basicUdiDi>735014659SecorimABOS8</basicUdiDi>
    <tradeName>SECORIM® ABO A-column</tradeName>
    <deviceName>SECORIM ABO columns</deviceName>
    <manufacturerName>VitroSorb AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01080102</emdnCode>
    <emdnDescription>IMMUNOADSORPTION COLUMNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:07:16.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414201340</udiDi>
    <basicUdiDi>7332414VA0000262Z</basicUdiDi>
    <tradeName>Prismaflex M100 set</tradeName>
    <deviceName>Prismaflex M set and Prismaflex ST set</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</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>106697MDR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:18.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414201302</udiDi>
    <basicUdiDi>7332414VA00002733</basicUdiDi>
    <tradeName>Prismaflex HF20 set</tradeName>
    <deviceName>Prismaflex HF20 set</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</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>109841MDR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:13.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414201265</udiDi>
    <basicUdiDi>7332414VA00002835</basicUdiDi>
    <tradeName>PRISMAFLEX SET</tradeName>
    <deviceName>Prismaflex HF1000-1400 sets</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</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>107140MDR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:13.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414201197</udiDi>
    <basicUdiDi>7332414VA0000172Y</basicUdiDi>
    <tradeName>Nephral ST</tradeName>
    <deviceName>Nephral ST</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</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>Nephral ST 200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:12.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200213</udiDi>
    <basicUdiDi>7332414VA0000152U</basicUdiDi>
    <tradeName>THERANOVA</tradeName>
    <deviceName>THERANOVA</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</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>THERANOVA 400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:11.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200190</udiDi>
    <basicUdiDi>7332414VA0000202M</basicUdiDi>
    <tradeName>Theralite 2100</tradeName>
    <deviceName>Theralite 2100</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010604</emdnCode>
    <emdnDescription>DIALYSERS FOR SPECIAL HAEMODIAFILTRATION AND OTHER THERAPIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113092A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:07.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200152</udiDi>
    <basicUdiDi>7332414VA00001934</basicUdiDi>
    <tradeName>REVACLEAR 300 APAC</tradeName>
    <deviceName>Revaclear</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</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>AB pazarı için değil</deviceStatus>
    <reference>Revaclear 300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:06.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200091</udiDi>
    <basicUdiDi>7332414VA0000142S</basicUdiDi>
    <tradeName>POLYFLUX 14 L</tradeName>
    <deviceName>Polyflux L</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060103</emdnCode>
    <emdnDescription>DIALYSERS - UFC &lt; 18 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Polyflux 14L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:05.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200022</udiDi>
    <basicUdiDi>7332414VA0000222R</basicUdiDi>
    <tradeName>POLYFLUX 140 H</tradeName>
    <deviceName>Polyflux H</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</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>Polyflux 140H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:05.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200015</udiDi>
    <basicUdiDi>7332414VA00001832</basicUdiDi>
    <tradeName>POLYFLUX 6H</tradeName>
    <deviceName>Polyflux 6H</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010604</emdnCode>
    <emdnDescription>DIALYSERS FOR SPECIAL HAEMODIAFILTRATION AND OTHER THERAPIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Polyflux 6H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:01.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332414200008</udiDi>
    <basicUdiDi>7332414VA0000212P</basicUdiDi>
    <tradeName>POLYFLUX 2H</tradeName>
    <deviceName>Polyflux 2H</deviceName>
    <manufacturerName>Vantive Health GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000038981</manufacturerSrn>
    <authorisedRepresentativeName>Vantive S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000041309</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010604</emdnCode>
    <emdnDescription>DIALYSERS FOR SPECIAL HAEMODIAFILTRATION AND OTHER THERAPIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Polyflux 2H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:08:00.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979848020003</udiDi>
    <basicUdiDi>6979848020000H7</basicUdiDi>
    <tradeName>Hollow Fiber Dialyzer</tradeName>
    <deviceName>Hollow Fiber Dialyzer</deviceName>
    <manufacturerName>Guangdong Zhongai Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010088</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS10</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:52:57.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973743090048</udiDi>
    <basicUdiDi>697374309004L8</basicUdiDi>
    <tradeName>SWS Medical Dialysis Fluid Filter</tradeName>
    <deviceName>Dialysis Fluid Filter</deviceName>
    <manufacturerName>TWT Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034143</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01080201</emdnCode>
    <emdnDescription>ENDOTOXIN REMOVAL FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWT-EF210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:00:01.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973556160402</udiDi>
    <basicUdiDi>697355616LFHTU</basicUdiDi>
    <tradeName>Low Flux Hemodialyzer</tradeName>
    <deviceName>Low Flux Hemodialyzer</deviceName>
    <manufacturerName>Jafron Blood Purification Technologies Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000006021</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060103</emdnCode>
    <emdnDescription>DIALYSERS - UFC &lt; 18 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JM-20L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:46:21.856Z</lastUpdated>
  </row>
</eudamedExport>