<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>04547327083225</udiDi>
    <basicUdiDi>B-04547327083225</basicUdiDi>
    <tradeName>SheathLessPV, 6 Fr, Angle45, 90cm</tradeName>
    <deviceName>SheathLessPV Peri-Vascular Guiding System</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>W8AN45-0-V090</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:08:50.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327083188</udiDi>
    <basicUdiDi>B-04547327083188</basicUdiDi>
    <tradeName>SheathLessPV, 6 Fr, Angle45, 55cm</tradeName>
    <deviceName>SheathLessPV Peri-Vascular Guiding System</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>W8AN45-0-V055</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:08:46.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327083140</udiDi>
    <basicUdiDi>B-04547327083140</basicUdiDi>
    <tradeName>SheathLessPV, 6 Fr, Standard, Straight, 90cm</tradeName>
    <deviceName>SheathLessPV Peri-Vascular Guiding System</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>W8ST00-0-V090</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:08:46.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327083102</udiDi>
    <basicUdiDi>B-04547327083102</basicUdiDi>
    <tradeName>SheathLessPV, 6 Fr, Standard, Straight, 55cm</tradeName>
    <deviceName>SheathLessPV Peri-Vascular Guiding System</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>W8ST00-0-V055</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:08:45.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327083164</udiDi>
    <basicUdiDi>B-04547327083164</basicUdiDi>
    <tradeName>SheathLessPV, 6 Fr, Standard, Straight, 120cm</tradeName>
    <deviceName>SheathLessPV Peri-Vascular Guiding System</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>W8ST00-0-V120</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:08:44.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183865</udiDi>
    <basicUdiDi>B-04540778183865</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-B40020LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:01.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183858</udiDi>
    <basicUdiDi>B-04540778183858</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-B35020LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:27:00.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183841</udiDi>
    <basicUdiDi>B-04540778183841</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-B30020LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:59.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183834</udiDi>
    <basicUdiDi>B-04540778183834</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-B25020LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:55.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183827</udiDi>
    <basicUdiDi>B-04540778183827</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-B20020LR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:54.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183810</udiDi>
    <basicUdiDi>B-04540778183810</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-B40020MR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:53.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183803</udiDi>
    <basicUdiDi>B-04540778183803</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-B35020MR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:53.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183797</udiDi>
    <basicUdiDi>B-04540778183797</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-B30020MR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:48.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183780</udiDi>
    <basicUdiDi>B-04540778183780</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-B25020MR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:47.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778183773</udiDi>
    <basicUdiDi>B-04540778183773</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-B20020MR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:47.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778167155</udiDi>
    <basicUdiDi>B-04540778167155</basicUdiDi>
    <tradeName>R2P Metacross RX</tradeName>
    <deviceName>R2P Metacross 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-P70200ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:47.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778167131</udiDi>
    <basicUdiDi>B-04540778167131</basicUdiDi>
    <tradeName>R2P Metacross RX</tradeName>
    <deviceName>R2P Metacross 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-P60200ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:41.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778167117</udiDi>
    <basicUdiDi>B-04540778167117</basicUdiDi>
    <tradeName>R2P Metacross RX</tradeName>
    <deviceName>R2P Metacross 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-P50200ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:41.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778167094</udiDi>
    <basicUdiDi>B-04540778167094</basicUdiDi>
    <tradeName>R2P Metacross RX</tradeName>
    <deviceName>R2P Metacross 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-P40200ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:40.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778167070</udiDi>
    <basicUdiDi>B-04540778167070</basicUdiDi>
    <tradeName>R2P Metacross RX</tradeName>
    <deviceName>R2P Metacross 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-P30200ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:26:39.457Z</lastUpdated>
  </row>
</eudamedExport>