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<eudamedExport entity="devices">
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    <udiDi>05901297137156</udiDi>
    <basicUdiDi>B-05901297137156</basicUdiDi>
    <tradeName>05901297137156</tradeName>
    <deviceName>SET FOR VENOUS INSUFFICIENCY TREATMENT FLEBOGRIF</deviceName>
    <manufacturerName>Balton Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000010568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901999</emdnCode>
    <emdnDescription>SYSTEMS FOR VESSEL EXTRACTION AND VEIN CLOSURE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLE6F60</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:18:26.931Z</lastUpdated>
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    <udiDi>00858254006015</udiDi>
    <basicUdiDi>B-00858254006015</basicUdiDi>
    <tradeName>Venclose EVSRF Catheter</tradeName>
    <deviceName>Venclose RF Ablation Catheter</deviceName>
    <manufacturerName>Venclose, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001372</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901902</emdnCode>
    <emdnDescription>RADIOFREQUENCY VENOUS ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VC-10A2.5-6F-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:35:08.301Z</lastUpdated>
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  <row>
    <udiDi>00858254006008</udiDi>
    <basicUdiDi>B-00858254006008</basicUdiDi>
    <tradeName>Venclose EVSRF Catheter</tradeName>
    <deviceName>Venclose RF Ablation Catheter</deviceName>
    <manufacturerName>Venclose, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001372</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901902</emdnCode>
    <emdnDescription>RADIOFREQUENCY VENOUS ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VC-10A2.5-6F-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:35:06.705Z</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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </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>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>
</eudamedExport>