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    <basicUdiDi>B-00813132024727</basicUdiDi>
    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>414-159</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:39.155Z</lastUpdated>
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    <udiDi>00813132024710</udiDi>
    <basicUdiDi>B-00813132024710</basicUdiDi>
    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>414-151</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:38.364Z</lastUpdated>
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    <udiDi>00813132024703</udiDi>
    <basicUdiDi>B-00813132024703</basicUdiDi>
    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410-154</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:23.083Z</lastUpdated>
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    <udiDi>00813132024697</udiDi>
    <basicUdiDi>B-00813132024697</basicUdiDi>
    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410-152</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:22.292Z</lastUpdated>
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    <udiDi>00813132023072</udiDi>
    <basicUdiDi>B-00813132023072</basicUdiDi>
    <tradeName>LLD EZ Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:18.275Z</lastUpdated>
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  <row>
    <udiDi>00813132023065</udiDi>
    <basicUdiDi>B-00813132023065</basicUdiDi>
    <tradeName>LLD EZ Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-067</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:17.486Z</lastUpdated>
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  <row>
    <udiDi>00813132023058</udiDi>
    <basicUdiDi>B-00813132023058</basicUdiDi>
    <tradeName>LLD E Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-039</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:16.689Z</lastUpdated>
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  <row>
    <udiDi>00813132023041</udiDi>
    <basicUdiDi>B-00813132023041</basicUdiDi>
    <tradeName>LLD #3 Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:15.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132023034</udiDi>
    <basicUdiDi>B-00813132023034</basicUdiDi>
    <tradeName>LLD #3 Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:11.869Z</lastUpdated>
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  <row>
    <udiDi>00813132023027</udiDi>
    <basicUdiDi>B-00813132023027</basicUdiDi>
    <tradeName>LLD #2 Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:11.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132023010</udiDi>
    <basicUdiDi>B-00813132023010</basicUdiDi>
    <tradeName>LLD #2 Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:10.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132023003</udiDi>
    <basicUdiDi>B-00813132023003</basicUdiDi>
    <tradeName>LLD #1 Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:09.505Z</lastUpdated>
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  <row>
    <udiDi>00813132022990</udiDi>
    <basicUdiDi>B-00813132022990</basicUdiDi>
    <tradeName>LLD #1 Lead Locking Device</tradeName>
    <deviceName>LLD Lead Locking Device</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>518-018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:05.483Z</lastUpdated>
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  <row>
    <udiDi>00813132022952</udiDi>
    <basicUdiDi>B-00813132022952</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>2290-60100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:04.669Z</lastUpdated>
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  <row>
    <udiDi>00813132022945</udiDi>
    <basicUdiDi>B-00813132022945</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>2290-50100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:03.878Z</lastUpdated>
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    <udiDi>00813132022938</udiDi>
    <basicUdiDi>B-00813132022938</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>2290-40100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:03.093Z</lastUpdated>
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    <udiDi>00813132022921</udiDi>
    <basicUdiDi>B-00813132022921</basicUdiDi>
    <tradeName>AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating</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>2216-35100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:59.066Z</lastUpdated>
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    <udiDi>00813132022914</udiDi>
    <basicUdiDi>B-00813132022914</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>2216-30100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:58.264Z</lastUpdated>
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    <udiDi>00813132022907</udiDi>
    <basicUdiDi>B-00813132022907</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>2216-25100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:57.487Z</lastUpdated>
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    <udiDi>00813132022891</udiDi>
    <basicUdiDi>B-00813132022891</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>2216-20100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:41:56.689Z</lastUpdated>
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