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<eudamedExport entity="devices">
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    <udiDi>00813132020989</udiDi>
    <basicUdiDi>B-00813132020989</basicUdiDi>
    <tradeName>QuickCat Catheter</tradeName>
    <deviceName>QuickCat Extraction 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>C019002</emdnCode>
    <emdnDescription>EMBOLECTOMY CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>60090-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:36.486Z</lastUpdated>
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  <row>
    <udiDi>00813132020972</udiDi>
    <basicUdiDi>B-00813132020972</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>555-513</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:35.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020965</udiDi>
    <basicUdiDi>B-00813132020965</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>555-511</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:20.407Z</lastUpdated>
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  <row>
    <udiDi>00813132020958</udiDi>
    <basicUdiDi>B-00813132020958</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>555-510</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:19.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020941</udiDi>
    <basicUdiDi>B-00813132020941</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>555-508</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:14.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020934</udiDi>
    <basicUdiDi>B-00813132020934</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>550-013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:14.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020927</udiDi>
    <basicUdiDi>B-00813132020927</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>550-011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:13.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020910</udiDi>
    <basicUdiDi>B-00813132020910</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>550-010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:12.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020903</udiDi>
    <basicUdiDi>B-00813132020903</basicUdiDi>
    <tradeName>SightRail Manual Dilator Sheath</tradeName>
    <deviceName>SightRail Manual 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>Artık piyasada değil</deviceStatus>
    <reference>550-008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:08.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020897</udiDi>
    <basicUdiDi>B-00813132020897</basicUdiDi>
    <tradeName>TightRail Rotating Dilator Sheath</tradeName>
    <deviceName>TightRail 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>545-513</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:07.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020880</udiDi>
    <basicUdiDi>B-00813132020880</basicUdiDi>
    <tradeName>TightRail Rotating Dilator Sheath</tradeName>
    <deviceName>TightRail 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>545-511</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:06.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020873</udiDi>
    <basicUdiDi>B-00813132020873</basicUdiDi>
    <tradeName>TightRail Rotating Dilator Sheath</tradeName>
    <deviceName>TightRail 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>545-509</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:05.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020811</udiDi>
    <basicUdiDi>B-00813132020811</basicUdiDi>
    <tradeName>LLD Accessory Kit</tradeName>
    <deviceName>LLD Accessory Kit</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>518-027</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:02.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020804</udiDi>
    <basicUdiDi>B-00813132020804</basicUdiDi>
    <tradeName>Lead Cutter</tradeName>
    <deviceName>LLD Lead Cutter</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>518-024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:39:00.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020712</udiDi>
    <basicUdiDi>B-00813132020712</basicUdiDi>
    <tradeName>Quick-Cross Support Catheter</tradeName>
    <deviceName>Quick-Cross 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>518-065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:59.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020705</udiDi>
    <basicUdiDi>B-00813132020705</basicUdiDi>
    <tradeName>Quick-Cross Support Catheter</tradeName>
    <deviceName>Quick-Cross 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>518-066</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:58.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020699</udiDi>
    <basicUdiDi>B-00813132020699</basicUdiDi>
    <tradeName>Quick-Cross Support Catheter</tradeName>
    <deviceName>Quick-Cross 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>518-038</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:54.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020682</udiDi>
    <basicUdiDi>B-00813132020682</basicUdiDi>
    <tradeName>Quick-Cross Support Catheter</tradeName>
    <deviceName>Quick-Cross 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>518-037</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:53.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020675</udiDi>
    <basicUdiDi>B-00813132020675</basicUdiDi>
    <tradeName>Quick-Cross Support Catheter</tradeName>
    <deviceName>Quick-Cross 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>518-036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:53.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020668</udiDi>
    <basicUdiDi>B-00813132020668</basicUdiDi>
    <tradeName>Quick-Cross Support Catheter</tradeName>
    <deviceName>Quick-Cross 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>518-035</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:52.394Z</lastUpdated>
  </row>
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