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<eudamedExport entity="devices">
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    <udiDi>04540778153936</udiDi>
    <basicUdiDi>B-04540778153936</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L40120ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778153950</udiDi>
    <basicUdiDi>B-04540778153950</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L50120ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778153974</udiDi>
    <basicUdiDi>B-04540778153974</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L60120ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778153998</udiDi>
    <basicUdiDi>B-04540778153998</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L70120ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154018</udiDi>
    <basicUdiDi>B-04540778154018</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L30150ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154032</udiDi>
    <basicUdiDi>B-04540778154032</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L40150ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154056</udiDi>
    <basicUdiDi>B-04540778154056</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L50150ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154070</udiDi>
    <basicUdiDi>B-04540778154070</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L60150ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154094</udiDi>
    <basicUdiDi>B-04540778154094</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L70150ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154117</udiDi>
    <basicUdiDi>B-04540778154117</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L30200ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:14.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154131</udiDi>
    <basicUdiDi>B-04540778154131</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L40200ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154155</udiDi>
    <basicUdiDi>B-04540778154155</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L50200ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154179</udiDi>
    <basicUdiDi>B-04540778154179</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L60200ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154193</udiDi>
    <basicUdiDi>B-04540778154193</basicUdiDi>
    <tradeName>Metacross RX</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L70200ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154216</udiDi>
    <basicUdiDi>B-04540778154216</basicUdiDi>
    <tradeName>Metacross OTW</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L30020SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154230</udiDi>
    <basicUdiDi>B-04540778154230</basicUdiDi>
    <tradeName>Metacross OTW</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L40020SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154254</udiDi>
    <basicUdiDi>B-04540778154254</basicUdiDi>
    <tradeName>Metacross OTW</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L50020SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154278</udiDi>
    <basicUdiDi>B-04540778154278</basicUdiDi>
    <tradeName>Metacross OTW</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L60020SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154292</udiDi>
    <basicUdiDi>B-04540778154292</basicUdiDi>
    <tradeName>Metacross OTW</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L70020SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778154315</udiDi>
    <basicUdiDi>B-04540778154315</basicUdiDi>
    <tradeName>Metacross OTW</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L80020SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.746Z</lastUpdated>
  </row>
</eudamedExport>