<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00813132020651</udiDi>
    <basicUdiDi>B-00813132020651</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>518-034</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:48.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020644</udiDi>
    <basicUdiDi>B-00813132020644</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>518-033</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:47.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020637</udiDi>
    <basicUdiDi>B-00813132020637</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>518-032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:46.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020446</udiDi>
    <basicUdiDi>B-00813132020446</basicUdiDi>
    <tradeName>TorqMax Sheath Grip Accessory</tradeName>
    <deviceName>TorqMax Sheath Grip Accessory</deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Y241899</emdnCode>
    <emdnDescription>ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>502-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:45.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020439</udiDi>
    <basicUdiDi>B-00813132020439</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-216</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:41.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020422</udiDi>
    <basicUdiDi>B-00813132020422</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-214</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:40.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020415</udiDi>
    <basicUdiDi>B-00813132020415</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-212</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:39.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020408</udiDi>
    <basicUdiDi>B-00813132020408</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-116</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:38.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020392</udiDi>
    <basicUdiDi>B-00813132020392</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-114</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:34.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020385</udiDi>
    <basicUdiDi>B-00813132020385</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-112</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:34.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020378</udiDi>
    <basicUdiDi>B-00813132020378</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:32.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020361</udiDi>
    <basicUdiDi>B-00813132020361</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:31.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020354</udiDi>
    <basicUdiDi>B-00813132020354</basicUdiDi>
    <tradeName>VisiSheath Dilator Sheath</tradeName>
    <deviceName>VisiSheath 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>501-012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:27.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020347</udiDi>
    <basicUdiDi>B-00813132020347</basicUdiDi>
    <tradeName>GlideLight Laser Sheath</tradeName>
    <deviceName>GlideLight Laser 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>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:26.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020330</udiDi>
    <basicUdiDi>B-00813132020330</basicUdiDi>
    <tradeName>GlideLight Laser Sheath</tradeName>
    <deviceName>GlideLight Laser 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>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:25.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020323</udiDi>
    <basicUdiDi>B-00813132020323</basicUdiDi>
    <tradeName>GlideLight Laser Sheath</tradeName>
    <deviceName>GlideLight Laser 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>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:25.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020316</udiDi>
    <basicUdiDi>B-00813132020316</basicUdiDi>
    <tradeName>SLS II Laser Sheath</tradeName>
    <deviceName>SLS II Laser 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>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>500-013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:21.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020309</udiDi>
    <basicUdiDi>B-00813132020309</basicUdiDi>
    <tradeName>SLS II Laser Sheath</tradeName>
    <deviceName>SLS II Laser 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>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>500-012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:20.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813132020293</udiDi>
    <basicUdiDi>B-00813132020293</basicUdiDi>
    <tradeName>SLS II Laser Sheath</tradeName>
    <deviceName>SLS II Laser 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>C01901903</emdnCode>
    <emdnDescription>VESSEL HARVESTING SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>500-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:38:18.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>20813132020440</udiDi>
    <basicUdiDi>B-20813132020440</basicUdiDi>
    <tradeName>TorqMax Sheath Grip Accessory</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spectranetics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020669</manufacturerSrn>
    <authorisedRepresentativeName>Spectranetics International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001484</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>502-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:41.325Z</lastUpdated>
  </row>
</eudamedExport>