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<eudamedExport entity="devices">
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    <udiDi>04540778145238</udiDi>
    <basicUdiDi>B-04540778145238</basicUdiDi>
    <tradeName>Raiden3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD3-20-350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778145245</udiDi>
    <basicUdiDi>B-04540778145245</basicUdiDi>
    <tradeName>Raiden3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD3-20-375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778145252</udiDi>
    <basicUdiDi>B-04540778145252</basicUdiDi>
    <tradeName>Raiden3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD3-20-400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778145269</udiDi>
    <basicUdiDi>B-04540778145269</basicUdiDi>
    <tradeName>Raiden3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD3-20-425</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778145276</udiDi>
    <basicUdiDi>B-04540778145276</basicUdiDi>
    <tradeName>Raiden3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD3-20-450</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778145986</udiDi>
    <basicUdiDi>B-04540778145986</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-6-100F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778145993</udiDi>
    <basicUdiDi>B-04540778145993</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-6-100P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146006</udiDi>
    <basicUdiDi>B-04540778146006</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146013</udiDi>
    <basicUdiDi>B-04540778146013</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146020</udiDi>
    <basicUdiDi>B-04540778146020</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146037</udiDi>
    <basicUdiDi>B-04540778146037</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:49.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146044</udiDi>
    <basicUdiDi>B-04540778146044</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-275</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146051</udiDi>
    <basicUdiDi>B-04540778146051</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146068</udiDi>
    <basicUdiDi>B-04540778146068</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146075</udiDi>
    <basicUdiDi>B-04540778146075</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146082</udiDi>
    <basicUdiDi>B-04540778146082</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-10-400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146099</udiDi>
    <basicUdiDi>B-04540778146099</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-15-150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146105</udiDi>
    <basicUdiDi>B-04540778146105</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-15-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146112</udiDi>
    <basicUdiDi>B-04540778146112</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-15-225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778146129</udiDi>
    <basicUdiDi>B-04540778146129</basicUdiDi>
    <tradeName>IKAZUCHI Zero</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000010091</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZE-15-250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:31:48.873Z</lastUpdated>
  </row>
</eudamedExport>