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    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L80040ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:35.159Z</lastUpdated>
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    <udiDi>04540778153394</udiDi>
    <basicUdiDi>B-04540778153394</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>Metacross RX</deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
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    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L70040ER</reference>
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    <lastUpdated>2026-08-02T06:08:34.509Z</lastUpdated>
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    <udiDi>04540778153370</udiDi>
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    <tradeName>Metacross RX</tradeName>
    <deviceName>Metacross RX</deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
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    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:31.161Z</lastUpdated>
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    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L40040ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:30.352Z</lastUpdated>
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    <udiDi>04540778153356</udiDi>
    <basicUdiDi>B-04540778153356</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L50040ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:28.758Z</lastUpdated>
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    <udiDi>04540778153295</udiDi>
    <basicUdiDi>B-04540778153295</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-LX2020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:26.351Z</lastUpdated>
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    <udiDi>04540778153318</udiDi>
    <basicUdiDi>B-04540778153318</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L30040ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:24.847Z</lastUpdated>
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    <udiDi>04540778153271</udiDi>
    <basicUdiDi>B-04540778153271</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-LX0020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:09.790Z</lastUpdated>
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    <udiDi>04540778153257</udiDi>
    <basicUdiDi>B-04540778153257</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L90020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:08.182Z</lastUpdated>
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    <udiDi>04540778153233</udiDi>
    <basicUdiDi>B-04540778153233</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L80020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:06.624Z</lastUpdated>
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    <udiDi>04540778153196</udiDi>
    <basicUdiDi>B-04540778153196</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L60020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:04.181Z</lastUpdated>
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    <udiDi>04540778153172</udiDi>
    <basicUdiDi>B-04540778153172</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L50020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:01.790Z</lastUpdated>
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    <udiDi>04540778153158</udiDi>
    <basicUdiDi>B-04540778153158</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L40020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:08:00.184Z</lastUpdated>
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    <udiDi>04540778153134</udiDi>
    <basicUdiDi>B-04540778153134</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L30020ER</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:07:59.380Z</lastUpdated>
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    <udiDi>04540778153110</udiDi>
    <basicUdiDi>B-04540778153110</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L70200CR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:07:57.994Z</lastUpdated>
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    <udiDi>04540778153097</udiDi>
    <basicUdiDi>B-04540778153097</basicUdiDi>
    <tradeName>Metacross RX</tradeName>
    <deviceName>Metacross RX</deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
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    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L60200CR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:07:55.381Z</lastUpdated>
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    <udiDi>04540778153073</udiDi>
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    <tradeName>Metacross RX</tradeName>
    <deviceName>Metacross RX</deviceName>
    <manufacturerName>KANEKA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022143</manufacturerSrn>
    <authorisedRepresentativeName>Kaneka Medical Europe N.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L50200CR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:07:53.785Z</lastUpdated>
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    <tradeName>Metacross RX</tradeName>
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    <manufacturerName>KANEKA Corporation</manufacturerName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD-L40200CR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:07:52.978Z</lastUpdated>
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    <tradeName>Metacross RX</tradeName>
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    <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-L30200CR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:07:51.378Z</lastUpdated>
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    <tradeName>Metacross RX</tradeName>
    <deviceName>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-L70150CR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T06:07:48.972Z</lastUpdated>
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