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    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2237-60100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:52.664Z</lastUpdated>
  </row>
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    <udiDi>00813132022839</udiDi>
    <basicUdiDi>B-00813132022839</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2237-50100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:51.863Z</lastUpdated>
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    <udiDi>00813132022822</udiDi>
    <basicUdiDi>B-00813132022822</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2237-40100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:51.058Z</lastUpdated>
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    <udiDi>00813132022808</udiDi>
    <basicUdiDi>B-00813132022808</basicUdiDi>
    <tradeName>TightRail Sub-C Rotating Dilator Sheath</tradeName>
    <deviceName>TightRail Sub-C Rotating Dilator Sheath</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9002</emdnCode>
    <emdnDescription>VASCULAR AND FASCIAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>560-013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:50.267Z</lastUpdated>
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    <udiDi>00813132022792</udiDi>
    <basicUdiDi>B-00813132022792</basicUdiDi>
    <tradeName>TightRail Sub-C Rotating Dilator Sheath</tradeName>
    <deviceName>TightRail Sub-C Rotating Dilator Sheath</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9002</emdnCode>
    <emdnDescription>VASCULAR AND FASCIAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>560-011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:46.281Z</lastUpdated>
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  <row>
    <udiDi>00813132022785</udiDi>
    <basicUdiDi>B-00813132022785</basicUdiDi>
    <tradeName>TightRail Sub-C Rotating Dilator Sheath</tradeName>
    <deviceName>TightRail Sub-C Rotating Dilator Sheath</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9002</emdnCode>
    <emdnDescription>VASCULAR AND FASCIAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>560-009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:45.462Z</lastUpdated>
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    <udiDi>00813132022259</udiDi>
    <basicUdiDi>B-00813132022259</basicUdiDi>
    <tradeName>Quick-Cross Extreme Support Catheter</tradeName>
    <deviceName>Quick-Cross Extreme Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-076</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:44.675Z</lastUpdated>
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  <row>
    <udiDi>00813132022242</udiDi>
    <basicUdiDi>B-00813132022242</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2334-8040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:43.860Z</lastUpdated>
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  <row>
    <udiDi>00813132022235</udiDi>
    <basicUdiDi>B-00813132022235</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2334-7040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:39.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132022228</udiDi>
    <basicUdiDi>B-00813132022228</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2333-8040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:39.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132022211</udiDi>
    <basicUdiDi>B-00813132022211</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2333-7040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:38.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132022204</udiDi>
    <basicUdiDi>B-00813132022204</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2332-8040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:37.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132022198</udiDi>
    <basicUdiDi>B-00813132022198</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter</tradeName>
    <deviceName>AngioSculpt PTA Scoring Balloon Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023203</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2332-7040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:22.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132021795</udiDi>
    <basicUdiDi>B-00813132021795</basicUdiDi>
    <tradeName>Quick-Cross Select Support Catheter</tradeName>
    <deviceName>Quick-Cross Select Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-093</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:21.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132021788</udiDi>
    <basicUdiDi>B-00813132021788</basicUdiDi>
    <tradeName>Quick-Cross Extreme Support Catheter</tradeName>
    <deviceName>Quick-Cross Extreme Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:17.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132021771</udiDi>
    <basicUdiDi>B-00813132021771</basicUdiDi>
    <tradeName>Quick-Cross Select Support Catheter</tradeName>
    <deviceName>Quick-Cross Select Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-091</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:16.583Z</lastUpdated>
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  <row>
    <udiDi>00813132021764</udiDi>
    <basicUdiDi>B-00813132021764</basicUdiDi>
    <tradeName>Quick-Cross Extreme Support Catheter</tradeName>
    <deviceName>Quick-Cross Extreme Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:15.791Z</lastUpdated>
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  <row>
    <udiDi>00813132021757</udiDi>
    <basicUdiDi>B-00813132021757</basicUdiDi>
    <tradeName>Quick-Cross Select Support Catheter</tradeName>
    <deviceName>Quick-Cross Select Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-089</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:14.986Z</lastUpdated>
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    <udiDi>00813132021740</udiDi>
    <basicUdiDi>B-00813132021740</basicUdiDi>
    <tradeName>Quick-Cross Extreme Support Catheter</tradeName>
    <deviceName>Quick-Cross Extreme Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-088</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:10.974Z</lastUpdated>
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  <row>
    <udiDi>00813132021733</udiDi>
    <basicUdiDi>B-00813132021733</basicUdiDi>
    <tradeName>Quick-Cross Select Support Catheter</tradeName>
    <deviceName>Quick-Cross Select Support Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020204</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>518-087</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:10.176Z</lastUpdated>
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</eudamedExport>