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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1532-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.382Z</lastUpdated>
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    <udiDi>05420040819861</udiDi>
    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000026759</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Medical Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000022416</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1538-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.367Z</lastUpdated>
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    <udiDi>05420040819878</udiDi>
    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1625-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.355Z</lastUpdated>
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    <udiDi>05420040819885</udiDi>
    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1632-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.342Z</lastUpdated>
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    <udiDi>05420040819892</udiDi>
    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1638-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.329Z</lastUpdated>
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    <udiDi>05420040819908</udiDi>
    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1725-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.320Z</lastUpdated>
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    <udiDi>05420040819915</udiDi>
    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1732-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.308Z</lastUpdated>
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    <udiDi>05420040819922</udiDi>
    <basicUdiDi>49684200TDA1102GR</basicUdiDi>
    <tradeName>SAFETOUCH DIALYSIS CATH PLUS</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TEMPORARY HEMODIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVSF-CATHP-1738-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.297Z</lastUpdated>
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    <udiDi>05420040820393</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-25HX-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.285Z</lastUpdated>
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  <row>
    <udiDi>05420040836035</udiDi>
    <basicUdiDi>49684200TDA1022GS</basicUdiDi>
    <tradeName>SOLACEA</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, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-15H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.270Z</lastUpdated>
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    <udiDi>05420040837001</udiDi>
    <basicUdiDi>49684200TDA1022GS</basicUdiDi>
    <tradeName>SOLACEA</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, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-19H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.258Z</lastUpdated>
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    <udiDi>05420040838008</udiDi>
    <basicUdiDi>49684200TDA1022GS</basicUdiDi>
    <tradeName>SOLACEA</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, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-21H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.246Z</lastUpdated>
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  <row>
    <udiDi>05420040839005</udiDi>
    <basicUdiDi>49684200TDA1022GS</basicUdiDi>
    <tradeName>SOLACEA</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, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLC-25H-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.235Z</lastUpdated>
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  <row>
    <udiDi>05420040840001</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 &lt; 18 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-11E-PO-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.223Z</lastUpdated>
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    <udiDi>05420040841008</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-15E-PO-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.214Z</lastUpdated>
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  <row>
    <udiDi>05420040842005</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-19E-PO-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.200Z</lastUpdated>
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  <row>
    <udiDi>05420040843002</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-21E-PO-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.186Z</lastUpdated>
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  <row>
    <udiDi>05420040844009</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 &lt; 18 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-03L-PO-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.174Z</lastUpdated>
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  <row>
    <udiDi>05420040845006</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 &lt; 18 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-05L-PO-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.162Z</lastUpdated>
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  <row>
    <udiDi>05420040846003</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 &lt; 18 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-07L-PO-GJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:08.150Z</lastUpdated>
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