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    <tradeName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</tradeName>
    <deviceName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</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>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A35SX040080135</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:43:11.177Z</lastUpdated>
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    <udiDi>00813132026134</udiDi>
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    <tradeName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</tradeName>
    <deviceName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</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>C010402020101</emdnCode>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A35SX040080080</reference>
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    <udiDi>00813132026127</udiDi>
    <basicUdiDi>B-00813132026127</basicUdiDi>
    <tradeName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</tradeName>
    <deviceName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</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>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:43:06.369Z</lastUpdated>
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    <udiDi>00813132026110</udiDi>
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    <tradeName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</tradeName>
    <deviceName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</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>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A35SX040060080</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:43:05.574Z</lastUpdated>
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    <udiDi>00813132026103</udiDi>
    <basicUdiDi>B-00813132026103</basicUdiDi>
    <tradeName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</tradeName>
    <deviceName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</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>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A35SX040040135</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:43:04.781Z</lastUpdated>
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    <udiDi>00813132026097</udiDi>
    <basicUdiDi>B-00813132026097</basicUdiDi>
    <tradeName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</tradeName>
    <deviceName>Stellarex 0.035" OTW Drug-coated Angioplasty Balloon</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>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A35SX040040080</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:43:03.974Z</lastUpdated>
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    <udiDi>00813132025472</udiDi>
    <basicUdiDi>B-00813132025472</basicUdiDi>
    <tradeName>ELCA Coronary Laser Atherectomy Catheter</tradeName>
    <deviceName>ELCA Coronary 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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020499</emdnCode>
    <emdnDescription>CORONARY ARTERY ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:59.967Z</lastUpdated>
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    <udiDi>00813132025458</udiDi>
    <basicUdiDi>B-00813132025458</basicUdiDi>
    <tradeName>ELCA Coronary Laser Atherectomy Catheter</tradeName>
    <deviceName>ELCA Coronary 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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020499</emdnCode>
    <emdnDescription>CORONARY ARTERY ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110-004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:59.168Z</lastUpdated>
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    <udiDi>00813132025441</udiDi>
    <basicUdiDi>B-00813132025441</basicUdiDi>
    <tradeName>ELCA Coronary Laser Atherectomy Catheter</tradeName>
    <deviceName>ELCA Coronary 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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020499</emdnCode>
    <emdnDescription>CORONARY ARTERY ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114-009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:58.368Z</lastUpdated>
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    <udiDi>00813132025434</udiDi>
    <basicUdiDi>B-00813132025434</basicUdiDi>
    <tradeName>ELCA Coronary Laser Atherectomy Catheter</tradeName>
    <deviceName>ELCA Coronary 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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020499</emdnCode>
    <emdnDescription>CORONARY ARTERY ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>117-016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:57.587Z</lastUpdated>
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    <udiDi>00813132025403</udiDi>
    <basicUdiDi>B-00813132025403</basicUdiDi>
    <tradeName>ELCA Coronary Laser Atherectomy Catheter</tradeName>
    <deviceName>ELCA Coronary 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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020499</emdnCode>
    <emdnDescription>CORONARY ARTERY ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:53.563Z</lastUpdated>
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    <udiDi>00813132024840</udiDi>
    <basicUdiDi>B-00813132024840</basicUdiDi>
    <tradeName>Bridge Occlusion Balloon</tradeName>
    <deviceName>Bridge Occlusion Balloon</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>C0104020103</emdnCode>
    <emdnDescription>VASCULAR OCCLUSION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>590-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:52.785Z</lastUpdated>
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    <udiDi>00813132024826</udiDi>
    <basicUdiDi>B-00813132024826</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>425-135-02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:51.963Z</lastUpdated>
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    <udiDi>00813132024802</udiDi>
    <basicUdiDi>B-00813132024802</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>423-135-02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:51.163Z</lastUpdated>
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    <udiDi>00813132024789</udiDi>
    <basicUdiDi>B-00813132024789</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>
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    <legislation>MDD</legislation>
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    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>425-011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:47.176Z</lastUpdated>
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    <udiDi>00813132024772</udiDi>
    <basicUdiDi>B-00813132024772</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:46.364Z</lastUpdated>
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    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:45.565Z</lastUpdated>
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    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
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    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:44.759Z</lastUpdated>
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    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
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    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C010402020699</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417-156</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:40.762Z</lastUpdated>
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    <tradeName>Turbo-Elite Laser Atherectomy Catheter</tradeName>
    <deviceName>Turbo-Elite Laser Atherectomy Catheter</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
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    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417-152</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:42:39.951Z</lastUpdated>
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