<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08720221012676</udiDi>
    <basicUdiDi>B-08720221012676</basicUdiDi>
    <tradeName>Focus np</tradeName>
    <deviceName>Focus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EFO22512</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:54.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720221012669</udiDi>
    <basicUdiDi>B-08720221012669</basicUdiDi>
    <tradeName>Focus np</tradeName>
    <deviceName>Focus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EFO40008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:49.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720221012652</udiDi>
    <basicUdiDi>B-08720221012652</basicUdiDi>
    <tradeName>Focus np</tradeName>
    <deviceName>Focus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EFO35008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:48.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720221012645</udiDi>
    <basicUdiDi>B-08720221012645</basicUdiDi>
    <tradeName>Focus np</tradeName>
    <deviceName>Focus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EFO30008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:47.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720221012638</udiDi>
    <basicUdiDi>B-08720221012638</basicUdiDi>
    <tradeName>Focus np</tradeName>
    <deviceName>Focus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EFO27508</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:47.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720221012621</udiDi>
    <basicUdiDi>B-08720221012621</basicUdiDi>
    <tradeName>Focus np</tradeName>
    <deviceName>Focus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EFO25008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:43.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720221012614</udiDi>
    <basicUdiDi>B-08720221012614</basicUdiDi>
    <tradeName>Focus np</tradeName>
    <deviceName>Focus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EFO22508</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:42.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720221010962</udiDi>
    <basicUdiDi>B-08720221010962</basicUdiDi>
    <tradeName>Abluminus np</tradeName>
    <deviceName>Abluminus np Sirolimus Based Nano Carrier Eluting Stent System</deviceName>
    <manufacturerName>Concept Medical B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402010302</emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EAP30040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:59:41.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024059</udiDi>
    <basicUdiDi>B-08888893024059</basicUdiDi>
    <tradeName>08888893024059</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>BFC1-3014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T12:13:16.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893024042</udiDi>
    <basicUdiDi>B-08888893024042</basicUdiDi>
    <tradeName>08888893024042</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>BFC1-3009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T12:13:16.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893014715</udiDi>
    <basicUdiDi>B-08888893014715</basicUdiDi>
    <tradeName>08888893014715</tradeName>
    <deviceName>BioFreedom</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>BFR1-3514</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T12:13:15.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028699</udiDi>
    <basicUdiDi>B-08888893028699</basicUdiDi>
    <tradeName>08888893028699</tradeName>
    <deviceName>BioFreedom</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>BFR1-3548</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:50.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028682</udiDi>
    <basicUdiDi>B-08888893028682</basicUdiDi>
    <tradeName>08888893028682</tradeName>
    <deviceName>BioFreedom</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>BFR1-3542</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:49.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028675</udiDi>
    <basicUdiDi>B-08888893028675</basicUdiDi>
    <tradeName>08888893028675</tradeName>
    <deviceName>BioFreedom</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>BFR1-3048</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:48.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028668</udiDi>
    <basicUdiDi>B-08888893028668</basicUdiDi>
    <tradeName>08888893028668</tradeName>
    <deviceName>BioFreedom</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>BFR1-3042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:48.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028651</udiDi>
    <basicUdiDi>B-08888893028651</basicUdiDi>
    <tradeName>08888893028651</tradeName>
    <deviceName>BioFreedom</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>BFR1-2748</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:42.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028644</udiDi>
    <basicUdiDi>B-08888893028644</basicUdiDi>
    <tradeName>08888893028644</tradeName>
    <deviceName>BioFreedom</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>BFR1-2742</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:41.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028637</udiDi>
    <basicUdiDi>B-08888893028637</basicUdiDi>
    <tradeName>08888893028637</tradeName>
    <deviceName>BioFreedom</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>BFR1-2548</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:40.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>08888893028620</udiDi>
    <basicUdiDi>B-08888893028620</basicUdiDi>
    <tradeName>08888893028620</tradeName>
    <deviceName>BioFreedom</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>BFR1-2542</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:55:40.136Z</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>2026-08-04T11:51:54.349Z</lastUpdated>
  </row>
</eudamedExport>