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    <basicUdiDi>B-04540778138575</basicUdiDi>
    <tradeName>Senri</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-S30120L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.353Z</lastUpdated>
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    <udiDi>04540778138582</udiDi>
    <basicUdiDi>B-04540778138582</basicUdiDi>
    <tradeName>Senri</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-S40120L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.325Z</lastUpdated>
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    <udiDi>04540778138599</udiDi>
    <basicUdiDi>B-04540778138599</basicUdiDi>
    <tradeName>Senri</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-S50120L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.292Z</lastUpdated>
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    <udiDi>04540778138605</udiDi>
    <basicUdiDi>B-04540778138605</basicUdiDi>
    <tradeName>Senri</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-S20150L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.267Z</lastUpdated>
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    <udiDi>04540778138612</udiDi>
    <basicUdiDi>B-04540778138612</basicUdiDi>
    <tradeName>Senri</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-S30150L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.242Z</lastUpdated>
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    <udiDi>04540778138629</udiDi>
    <basicUdiDi>B-04540778138629</basicUdiDi>
    <tradeName>Senri</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-S40150L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.219Z</lastUpdated>
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    <udiDi>04540778138636</udiDi>
    <basicUdiDi>B-04540778138636</basicUdiDi>
    <tradeName>Senri</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-S50150L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138643</udiDi>
    <basicUdiDi>B-04540778138643</basicUdiDi>
    <tradeName>Senri</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-S7040LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.167Z</lastUpdated>
  </row>
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    <udiDi>04540778138650</udiDi>
    <basicUdiDi>B-04540778138650</basicUdiDi>
    <tradeName>Senri</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-S8040LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.140Z</lastUpdated>
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    <udiDi>04540778138674</udiDi>
    <basicUdiDi>B-04540778138674</basicUdiDi>
    <tradeName>Senri</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-S7060LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138681</udiDi>
    <basicUdiDi>B-04540778138681</basicUdiDi>
    <tradeName>Senri</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-S8060LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138698</udiDi>
    <basicUdiDi>B-04540778138698</basicUdiDi>
    <tradeName>Senri</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-S6080LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:17.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138704</udiDi>
    <basicUdiDi>B-04540778138704</basicUdiDi>
    <tradeName>Senri</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-S7080LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138711</udiDi>
    <basicUdiDi>B-04540778138711</basicUdiDi>
    <tradeName>Senri</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-S60100LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138728</udiDi>
    <basicUdiDi>B-04540778138728</basicUdiDi>
    <tradeName>Senri</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-S60120LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138735</udiDi>
    <basicUdiDi>B-04540778138735</basicUdiDi>
    <tradeName>Senri</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-S60150LH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778138797</udiDi>
    <basicUdiDi>B-04540778138797</basicUdiDi>
    <tradeName>ELECTRO DETACH GENERATOR v4</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>347-404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778141889</udiDi>
    <basicUdiDi>B-04540778141889</basicUdiDi>
    <tradeName>ED COIL</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>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>352-1610R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778141902</udiDi>
    <basicUdiDi>B-04540778141902</basicUdiDi>
    <tradeName>ED COIL</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>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>352-1620R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778141919</udiDi>
    <basicUdiDi>B-04540778141919</basicUdiDi>
    <tradeName>ED COIL</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>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>352-1630R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:16.849Z</lastUpdated>
  </row>
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