<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05430003353011</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353011</tradeName>
    <deviceName>Procedure pack KME</deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET LPS-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:11:33.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353028</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353028</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET LPS-50 S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353035</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353035</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET LPS-75</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353042</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353042</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET LPS-75 S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353059</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353059</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET LPS-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353066</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353066</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET LPS-100 S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353073</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353073</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET43</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353080</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353080</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET43 B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353097</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353097</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET43A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353103</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353103</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET43A B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353110</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353110</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET MEDICA 400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353127</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353127</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET MEDICA 400 B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353134</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353134</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET MEDICA 600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353141</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353141</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET MEDICA 600 B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353158</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353158</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET MEDICA 700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353165</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353165</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET MEDICA 700 B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353172</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353172</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET6X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353189</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353189</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET6X B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353196</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353196</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET6X S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430003353219</udiDi>
    <basicUdiDi>5430003353APHERESEAB</basicUdiDi>
    <tradeName>05430003353219</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaneka Medical Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-PR-000019754</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC APHERESIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET7X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:03.335Z</lastUpdated>
  </row>
</eudamedExport>