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<eudamedExport entity="devices">
  <row>
    <udiDi>00802526594038</udiDi>
    <basicUdiDi>01915060000000000000084MY</basicUdiDi>
    <tradeName>PERCIVA™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594045</udiDi>
    <basicUdiDi>01915060000000000000084MY</basicUdiDi>
    <tradeName>CHARISMA™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594052</udiDi>
    <basicUdiDi>01915060000000000000084MY</basicUdiDi>
    <tradeName>VIGILANT™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594069</udiDi>
    <basicUdiDi>01915060000000000000084MY</basicUdiDi>
    <tradeName>RESONATE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D433</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178567</udiDi>
    <basicUdiDi>B-00763000178567</basicUdiDi>
    <tradeName>Crome™ VR MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome ICD</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVPC3D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:09.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178529</udiDi>
    <basicUdiDi>B-00763000178529</basicUdiDi>
    <tradeName>Cobalt™ VR MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome ICD</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVPB3D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:08.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178482</udiDi>
    <basicUdiDi>B-00763000178482</basicUdiDi>
    <tradeName>Cobalt™ XT VR MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome ICD</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVPA2D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:06.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178475</udiDi>
    <basicUdiDi>B-00763000178475</basicUdiDi>
    <tradeName>Cobalt™ XT VR MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome ICD</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVPA2D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-10T19:49:02.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000206369</udiDi>
    <basicUdiDi>B-00763000206369</basicUdiDi>
    <tradeName>Visia AF MRI™ S VR SureScan™</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVFC3D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-07T19:37:09.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169353916</udiDi>
    <basicUdiDi>B-00643169353916</basicUdiDi>
    <tradeName>Evera™ XT VR</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVBB2D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-07T19:37:09.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169017924</udiDi>
    <basicUdiDi>B-00643169017924</basicUdiDi>
    <tradeName>Evera™ XT VR</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVBB2D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-07T19:37:09.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169017931</udiDi>
    <basicUdiDi>B-00643169017931</basicUdiDi>
    <tradeName>Evera™ XT VR</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVBB2D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-07T19:37:09.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169566361</udiDi>
    <basicUdiDi>B-00643169566361</basicUdiDi>
    <tradeName>Visia AF™</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVAB2D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-07T19:37:09.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000206338</udiDi>
    <basicUdiDi>B-00763000206338</basicUdiDi>
    <tradeName>Visia AF MRI™ XT VR SureScan™</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVFB2D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:10.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169720800</udiDi>
    <basicUdiDi>B-00643169720800</basicUdiDi>
    <tradeName>Visia AF MRI™ XT VR SureScan™</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVFB2D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:52:04.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169672772</udiDi>
    <basicUdiDi>B-00643169672772</basicUdiDi>
    <tradeName>Visia AF MRI™ XT VR SureScan™</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVFB2D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:36.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169566439</udiDi>
    <basicUdiDi>B-00643169566439</basicUdiDi>
    <tradeName>Visia AF MRI™ XT VR SureScan™</tradeName>
    <deviceName>Evera,Visia AF, Primo/Mirro w  MRI</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DVFB2D4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:32.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178543</udiDi>
    <basicUdiDi>B-00763000178543</basicUdiDi>
    <tradeName>Crome™ VR MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome ICD</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVPC3D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:51:10.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178505</udiDi>
    <basicUdiDi>B-00763000178505</basicUdiDi>
    <tradeName>Cobalt™ VR MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome ICD</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVPB3D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:08:40.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>08031527014395</udiDi>
    <basicUdiDi>B-08031527014395</basicUdiDi>
    <tradeName>PLATINIUM VR 1240</tradeName>
    <deviceName>Implantable Cardioverter / Defibrillators PLATINIUM</deviceName>
    <manufacturerName>MicroPort CRM S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000029013</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TDF035C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T00:20:52.643Z</lastUpdated>
  </row>
</eudamedExport>