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<eudamedExport entity="devices">
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    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</tradeName>
    <deviceName>SAFETY HEMODIALYSIS NEEDLE</deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1525-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:00:38.545Z</lastUpdated>
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  <row>
    <udiDi>05420040811643</udiDi>
    <basicUdiDi>49684200TDA1022GS</basicUdiDi>
    <tradeName>SOLACEA</tradeName>
    <deviceName>HEMODIALYZER</deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-17H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:00:37.738Z</lastUpdated>
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  <row>
    <udiDi>05420040801576</udiDi>
    <basicUdiDi>49684200TDA1021GQ</basicUdiDi>
    <tradeName>SUREFLUX</tradeName>
    <deviceName>HEMODIALYZER</deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-11UX-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:00:36.937Z</lastUpdated>
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    <udiDi>05420040801279</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName>SYNTHETIC HEMODIALYZER</deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-09H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:00:34.535Z</lastUpdated>
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  <row>
    <udiDi>04968420722635</udiDi>
    <basicUdiDi>4968420TDHE1011XW</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName>SYNTHETIC HEMODIALYZER</deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-13H-GC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:52.076Z</lastUpdated>
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  <row>
    <udiDi>05420040801286</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-11H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.846Z</lastUpdated>
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  <row>
    <udiDi>05420040801293</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-13H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.836Z</lastUpdated>
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  <row>
    <udiDi>05420040801309</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-15H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801316</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-17H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.803Z</lastUpdated>
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  <row>
    <udiDi>05420040801323</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-19H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801330</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-21H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801347</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-25H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801361</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &lt; 18 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-11M-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801378</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC &lt; 18 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-13M-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801385</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-15M-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801392</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-17M-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801408</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-19M-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801415</udiDi>
    <basicUdiDi>49684200TDA1011GM</basicUdiDi>
    <tradeName>ELISIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELI-21M-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801583</udiDi>
    <basicUdiDi>49684200TDA1021GQ</basicUdiDi>
    <tradeName>SUREFLUX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-13UX-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420040801590</udiDi>
    <basicUdiDi>49684200TDA1021GQ</basicUdiDi>
    <tradeName>SUREFLUX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-15UX-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:10.546Z</lastUpdated>
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