<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08888893024653</udiDi>
    <basicUdiDi>B-08888893024653</basicUdiDi>
    <tradeName>08888893024653</tradeName>
    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-20020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:50.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024646</udiDi>
    <basicUdiDi>B-08888893024646</basicUdiDi>
    <tradeName>08888893024646</tradeName>
    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-20015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:48.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024639</udiDi>
    <basicUdiDi>B-08888893024639</basicUdiDi>
    <tradeName>08888893024639</tradeName>
    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-20012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:43.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024622</udiDi>
    <basicUdiDi>B-08888893024622</basicUdiDi>
    <tradeName>08888893024622</tradeName>
    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-20010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:41.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024615</udiDi>
    <basicUdiDi>B-08888893024615</basicUdiDi>
    <tradeName>08888893024615</tradeName>
    <deviceName>RISE NC</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCB-20008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:40.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024226</udiDi>
    <basicUdiDi>B-08888893024226</basicUdiDi>
    <tradeName>08888893024226</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-4029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:37.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024219</udiDi>
    <basicUdiDi>B-08888893024219</basicUdiDi>
    <tradeName>08888893024219</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-4024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:34.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024202</udiDi>
    <basicUdiDi>B-08888893024202</basicUdiDi>
    <tradeName>08888893024202</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-4019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:31.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024196</udiDi>
    <basicUdiDi>B-08888893024196</basicUdiDi>
    <tradeName>08888893024196</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-4014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:29.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024189</udiDi>
    <basicUdiDi>B-08888893024189</basicUdiDi>
    <tradeName>08888893024189</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-4009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:26.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024172</udiDi>
    <basicUdiDi>B-08888893024172</basicUdiDi>
    <tradeName>08888893024172</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3536</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:23.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024165</udiDi>
    <basicUdiDi>B-08888893024165</basicUdiDi>
    <tradeName>08888893024165</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3533</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:20.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024158</udiDi>
    <basicUdiDi>B-08888893024158</basicUdiDi>
    <tradeName>08888893024158</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3529</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:19.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024141</udiDi>
    <basicUdiDi>B-08888893024141</basicUdiDi>
    <tradeName>08888893024141</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3524</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:17.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024134</udiDi>
    <basicUdiDi>B-08888893024134</basicUdiDi>
    <tradeName>08888893024134</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3519</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:12.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024127</udiDi>
    <basicUdiDi>B-08888893024127</basicUdiDi>
    <tradeName>08888893024127</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3514</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:09.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024110</udiDi>
    <basicUdiDi>B-08888893024110</basicUdiDi>
    <tradeName>08888893024110</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3509</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:08.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024103</udiDi>
    <basicUdiDi>B-08888893024103</basicUdiDi>
    <tradeName>08888893024103</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:06.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024097</udiDi>
    <basicUdiDi>B-08888893024097</basicUdiDi>
    <tradeName>08888893024097</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3033</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:02.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024080</udiDi>
    <basicUdiDi>B-08888893024080</basicUdiDi>
    <tradeName>08888893024080</tradeName>
    <deviceName>BioFreedom Ultra</deviceName>
    <manufacturerName>Biosensors Europe SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015764</manufacturerSrn>
    <authorisedRepresentativeName>NVT GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006441</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFC1-3029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:38:00.372Z</lastUpdated>
  </row>
</eudamedExport>