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<eudamedExport entity="devices">
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    <udiDi>00643169708280</udiDi>
    <basicUdiDi>B-00643169708280</basicUdiDi>
    <tradeName>CapSureFix Novus MRI™ SureScan™</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407685</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:42.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169708273</udiDi>
    <basicUdiDi>B-00643169708273</basicUdiDi>
    <tradeName>CapSureFix Novus MRI™ SureScan™</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407665</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:38.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169708266</udiDi>
    <basicUdiDi>B-00643169708266</basicUdiDi>
    <tradeName>CapSureFix Novus MRI™ SureScan™</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407658</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:37.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169708259</udiDi>
    <basicUdiDi>B-00643169708259</basicUdiDi>
    <tradeName>CapSureFix Novus MRI™ SureScan™</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407652</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:37.204Z</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>00613994945662</udiDi>
    <basicUdiDi>B-00613994945662</basicUdiDi>
    <tradeName>CAPSUREFIX® NOVUS</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407658</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:24.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>00613994945655</udiDi>
    <basicUdiDi>B-00613994945655</basicUdiDi>
    <tradeName>CAPSUREFIX® NOVUS</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407658</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:23.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>00613994945648</udiDi>
    <basicUdiDi>B-00613994945648</basicUdiDi>
    <tradeName>CAPSUREFIX® NOVUS</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407652</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:19.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>00613994945631</udiDi>
    <basicUdiDi>B-00613994945631</basicUdiDi>
    <tradeName>CAPSUREFIX® NOVUS</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407652</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:51:18.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>00885074406411</udiDi>
    <basicUdiDi>B-00885074406411</basicUdiDi>
    <tradeName>CAPSUREFIX® NOVUS</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407658</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:10:30.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>00885074406404</udiDi>
    <basicUdiDi>B-00885074406404</basicUdiDi>
    <tradeName>CAPSUREFIX® NOVUS</tradeName>
    <deviceName>CapSureFix Novus Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407652</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:10:26.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>00885074239491</udiDi>
    <basicUdiDi>B-00885074239491</basicUdiDi>
    <tradeName>CAPSURE® SENSE</tradeName>
    <deviceName>4574 CapSure Sense Lead</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>J0190010102</emdnCode>
    <emdnDescription>ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>457453</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:10:25.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04035479139315H8</udiDi>
    <basicUdiDi>B-04035479139315H8</basicUdiDi>
    <tradeName>D-04035479139315H8</tradeName>
    <deviceName>CardioMessenger Smart 2G</deviceName>
    <manufacturerName>BIOTRONIK SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J010780</emdnCode>
    <emdnDescription>ACTIVE IMPLANTABLE CARDIAC DEVICES REMOTE MONITORING SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>401826</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T19:39:48.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020174</udiDi>
    <basicUdiDi>B-00813787020174</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX6510iN, XX6515iN or XX6520iN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T03:59:11.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787022147</udiDi>
    <basicUdiDi>B-00813787022147</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX6510iN, XX6515iN or XX6520iN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:26.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020167</udiDi>
    <basicUdiDi>B-00813787020167</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX6510i, XX6515i or XX6520i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:24.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020143</udiDi>
    <basicUdiDi>B-00813787020143</basicUdiDi>
    <tradeName>AgX100® I125 Implants</tradeName>
    <deviceName>AgX100® I125 Implants</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX65XXiX orXX650Xi</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:22.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020099</udiDi>
    <basicUdiDi>B-00813787020099</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX509iN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:20.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020082</udiDi>
    <basicUdiDi>B-00813787020082</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX508i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:20.004Z</lastUpdated>
  </row>
</eudamedExport>