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    <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-L30080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.085Z</lastUpdated>
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    <udiDi>04540778154759</udiDi>
    <basicUdiDi>B-04540778154759</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-L40080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.055Z</lastUpdated>
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    <udiDi>04540778154773</udiDi>
    <basicUdiDi>B-04540778154773</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-L50080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:13.021Z</lastUpdated>
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    <udiDi>04540778154797</udiDi>
    <basicUdiDi>B-04540778154797</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-L60080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.986Z</lastUpdated>
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    <udiDi>04540778154810</udiDi>
    <basicUdiDi>B-04540778154810</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-L70080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.955Z</lastUpdated>
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    <udiDi>04540778154834</udiDi>
    <basicUdiDi>B-04540778154834</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-L80080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.931Z</lastUpdated>
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    <udiDi>04540778154858</udiDi>
    <basicUdiDi>B-04540778154858</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-L90080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.902Z</lastUpdated>
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    <udiDi>04540778154872</udiDi>
    <basicUdiDi>B-04540778154872</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-LX0080SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.864Z</lastUpdated>
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    <udiDi>04540778154896</udiDi>
    <basicUdiDi>B-04540778154896</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-L30100SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.828Z</lastUpdated>
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    <udiDi>04540778154933</udiDi>
    <basicUdiDi>B-04540778154933</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-L50100SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.761Z</lastUpdated>
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    <udiDi>04540778154957</udiDi>
    <basicUdiDi>B-04540778154957</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-L60100SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.725Z</lastUpdated>
  </row>
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    <udiDi>04540778154971</udiDi>
    <basicUdiDi>B-04540778154971</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-L70100SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.694Z</lastUpdated>
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    <udiDi>04540778154995</udiDi>
    <basicUdiDi>B-04540778154995</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-L30120SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778155015</udiDi>
    <basicUdiDi>B-04540778155015</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-L40120SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778155039</udiDi>
    <basicUdiDi>B-04540778155039</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-L50120SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>04540778155053</udiDi>
    <basicUdiDi>B-04540778155053</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-L60120SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.547Z</lastUpdated>
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    <udiDi>04540778155077</udiDi>
    <basicUdiDi>B-04540778155077</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-L70120SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.511Z</lastUpdated>
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    <udiDi>04540778155091</udiDi>
    <basicUdiDi>B-04540778155091</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-L30150SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.482Z</lastUpdated>
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    <udiDi>04540778155114</udiDi>
    <basicUdiDi>B-04540778155114</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-L40150SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.435Z</lastUpdated>
  </row>
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    <udiDi>04540778155138</udiDi>
    <basicUdiDi>B-04540778155138</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-L50150SW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:11:12.399Z</lastUpdated>
  </row>
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