<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04540778165786</udiDi>
    <basicUdiDi>B-04540778165786</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-0304RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:52.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165779</udiDi>
    <basicUdiDi>B-04540778165779</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-0303RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:51.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165762</udiDi>
    <basicUdiDi>B-04540778165762</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-02H6RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:50.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165755</udiDi>
    <basicUdiDi>B-04540778165755</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-02H4RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:46.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165748</udiDi>
    <basicUdiDi>B-04540778165748</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-02H3RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:45.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165731</udiDi>
    <basicUdiDi>B-04540778165731</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-0208RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:45.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165724</udiDi>
    <basicUdiDi>B-04540778165724</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-0206RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:44.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165700</udiDi>
    <basicUdiDi>B-04540778165700</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-0203RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:40.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165687</udiDi>
    <basicUdiDi>B-04540778165687</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-01H3RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:39.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165694</udiDi>
    <basicUdiDi>B-04540778165694</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-0202RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:27.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165670</udiDi>
    <basicUdiDi>B-04540778165670</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-01H2RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:23.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778165663</udiDi>
    <basicUdiDi>B-04540778165663</basicUdiDi>
    <tradeName>ED COIL</tradeName>
    <deviceName>ED COIL</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>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>353-01H1RS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:22.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163515</udiDi>
    <basicUdiDi>B-04540778163515</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B40200LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:21.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163492</udiDi>
    <basicUdiDi>B-04540778163492</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B35200LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:20.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163478</udiDi>
    <basicUdiDi>B-04540778163478</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B30200LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:16.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163454</udiDi>
    <basicUdiDi>B-04540778163454</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B25200LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:16.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163430</udiDi>
    <basicUdiDi>B-04540778163430</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B20200LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:15.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163416</udiDi>
    <basicUdiDi>B-04540778163416</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B40150LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:14.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163393</udiDi>
    <basicUdiDi>B-04540778163393</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B35150LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:10.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778163379</udiDi>
    <basicUdiDi>B-04540778163379</basicUdiDi>
    <tradeName>Crosperio RX</tradeName>
    <deviceName>Crosperio RX</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-B30150LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:22:09.761Z</lastUpdated>
  </row>
</eudamedExport>