<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>09555793109023</udiDi>
    <basicUdiDi>B-09555793109023</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA21L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:20.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109016</udiDi>
    <basicUdiDi>B-09555793109016</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA19L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:19.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793109009</udiDi>
    <basicUdiDi>B-09555793109009</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA17L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:18.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108996</udiDi>
    <basicUdiDi>B-09555793108996</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA15L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:17.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108989</udiDi>
    <basicUdiDi>B-09555793108989</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIA13L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:13.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108668</udiDi>
    <basicUdiDi>B-09555793108668</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2517SR03TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:13.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108651</udiDi>
    <basicUdiDi>B-09555793108651</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2516SR03TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:12.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108644</udiDi>
    <basicUdiDi>B-09555793108644</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2515SR03TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:11.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108156</udiDi>
    <basicUdiDi>B-09555793108156</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF3215LR01ASG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:08.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108149</udiDi>
    <basicUdiDi>B-09555793108149</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-20LF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:06.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108132</udiDi>
    <basicUdiDi>B-09555793108132</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-18LF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:05.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108125</udiDi>
    <basicUdiDi>B-09555793108125</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-16LF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:04.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793108118</udiDi>
    <basicUdiDi>B-09555793108118</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>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-14LF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:02.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793104868</udiDi>
    <basicUdiDi>B-09555793104868</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2014LR01SG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:13:00.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793104820</udiDi>
    <basicUdiDi>B-09555793104820</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2015LR01SG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:12:59.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793104783</udiDi>
    <basicUdiDi>B-09555793104783</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2016LR01SG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:12:57.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793104745</udiDi>
    <basicUdiDi>B-09555793104745</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2017LR01SG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:12:55.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555793104189</udiDi>
    <basicUdiDi>B-09555793104189</basicUdiDi>
    <tradeName>Disposable AV Fistula Needle Sets (Safety Needle Series)</tradeName>
    <deviceName>Disposable AV Fistula Needle Sets (Safety Needle Series)</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF2515LR01SG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:12:53.943Z</lastUpdated>
  </row>
</eudamedExport>