<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04540778115620</udiDi>
    <basicUdiDi>B-04540778115620</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>350-0515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:56:39.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04993478010021</udiDi>
    <basicUdiDi>4993478KNK00642</basicUdiDi>
    <tradeName>LIPOSORBER</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>PLASMAPHERESIS DEVICES AND KITS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:08:29.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>04993478010083</udiDi>
    <basicUdiDi>B-04993478010083</basicUdiDi>
    <tradeName>LIPOSORBER D (DL-50)</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>APHERESIS THERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:08:29.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>04993478010090</udiDi>
    <basicUdiDi>B-04993478010090</basicUdiDi>
    <tradeName>LIPOSORBER D (DL-75)</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>APHERESIS THERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL-75</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:08:29.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778186330</udiDi>
    <basicUdiDi>4993478KNK0053Y</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>347-404R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:09:00.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778157453</udiDi>
    <basicUdiDi>4993478KNK0013Q</basicUdiDi>
    <tradeName>Crosstella 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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-F20020MR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:08:59.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778107489</udiDi>
    <basicUdiDi>B-04540778107489</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>350-0209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115569</udiDi>
    <basicUdiDi>B-04540778115569</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>350-0312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115590</udiDi>
    <basicUdiDi>B-04540778115590</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>350-0412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115651</udiDi>
    <basicUdiDi>B-04540778115651</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>350-0620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115682</udiDi>
    <basicUdiDi>B-04540778115682</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>350-0730</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115712</udiDi>
    <basicUdiDi>B-04540778115712</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>350-0830</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115743</udiDi>
    <basicUdiDi>B-04540778115743</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>350-0930</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115774</udiDi>
    <basicUdiDi>B-04540778115774</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>350-1030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778115835</udiDi>
    <basicUdiDi>B-04540778115835</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>350-1230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778118010</udiDi>
    <basicUdiDi>B-04540778118010</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>352-0306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778118027</udiDi>
    <basicUdiDi>B-04540778118027</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>352-0308</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:19.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778118041</udiDi>
    <basicUdiDi>B-04540778118041</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>352-0408</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:18.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778118058</udiDi>
    <basicUdiDi>B-04540778118058</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>352-0412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:18.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778118065</udiDi>
    <basicUdiDi>B-04540778118065</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>352-0508</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:41:18.951Z</lastUpdated>
  </row>
</eudamedExport>