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<eudamedExport entity="devices">
  <row>
    <udiDi>07640183760037</udiDi>
    <basicUdiDi>B-07640183760037</basicUdiDi>
    <tradeName>directSTIM 12-connector extension</tradeName>
    <deviceName>directSTIM 12-connector extension kit</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:23.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760020</udiDi>
    <basicUdiDi>B-07640183760020</basicUdiDi>
    <tradeName>directSTIM 24-channel Implantable Pulse Generator</tradeName>
    <deviceName>directSTIM 24-channel Implantable Pulse Generator</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J02010101</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) IMPLANTABLE NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:22.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760013</udiDi>
    <basicUdiDi>B-07640183760013</basicUdiDi>
    <tradeName>directSTIM 12-electrode lead</tradeName>
    <deviceName>directSTIM 12-electrode lead kit</deviceName>
    <manufacturerName>Aleva Neurotherapeutics SA</manufacturerName>
    <manufacturerSrn>CH-MF-000015804</manufacturerSrn>
    <authorisedRepresentativeName>Veranex Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005578</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020102</emdnCode>
    <emdnDescription>DEEP BRAIN STIMULATION (DBS) LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:22.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770025266022</udiDi>
    <basicUdiDi>B-03770025266022</basicUdiDi>
    <tradeName>Alert Management Solution</tradeName>
    <deviceName>Alert Management Solution</deviceName>
    <manufacturerName>Implicity</manufacturerName>
    <manufacturerSrn>FR-MF-000014184</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010792</emdnCode>
    <emdnDescription>ACTIVE IMPLANTABLE CARDIAC DEVICES REMOTE MONITORING SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM009</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:02.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860014024832</udiDi>
    <basicUdiDi>B-00860014024832</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>Introducer Kit BVX-150RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-150RTC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:48.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860014024818</udiDi>
    <basicUdiDi>B-00860014024818</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>LV-LV Anchor Kit, Curved Needle-20 BVX-120RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-120RTC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:46.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860014024801</udiDi>
    <basicUdiDi>B-00860014024801</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>Anchor Kit, Flex BVX-110RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-110RTC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:46.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860014024825</udiDi>
    <basicUdiDi>B-00860014024825</basicUdiDi>
    <tradeName>Revivent TC</tradeName>
    <deviceName>TransThoracic Force Gauge BVX-145RTC</deviceName>
    <manufacturerName>BioVentrix Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044097</manufacturerSrn>
    <authorisedRepresentativeName>Meditrial Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007805</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J010399</emdnCode>
    <emdnDescription>IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVX-145RTC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:44.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859144004173</udiDi>
    <basicUdiDi>B-00859144004173</basicUdiDi>
    <tradeName>Carotid Sinus Lead Repair Kit</tradeName>
    <deviceName>Carotid Sinus Lead Repair Kit</deviceName>
    <manufacturerName>CVRx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001082</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0280</emdnCode>
    <emdnDescription>IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100056-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:42:16.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859144004050</udiDi>
    <basicUdiDi>B-00859144004050</basicUdiDi>
    <tradeName>Programmer System</tradeName>
    <deviceName>Programmer System</deviceName>
    <manufacturerName>CVRx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001082</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020701</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100055-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:42:15.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859144004012</udiDi>
    <basicUdiDi>B-00859144004012</basicUdiDi>
    <tradeName>Barostim Legacy Implantable Pulse Generator</tradeName>
    <deviceName>Barostim Legacy Implantable Pulse Generator</deviceName>
    <manufacturerName>CVRx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001082</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0209</emdnCode>
    <emdnDescription>CAROTID SINUS IMPLANTABLE NEUROSTIMULATORS AND LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100053-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:42:14.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007353</udiDi>
    <basicUdiDi>B-00857688007353</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede Programmer Power Supply and USB cable</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:45.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007346</udiDi>
    <basicUdiDi>B-00857688007346</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede eIPG</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:29.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007339</udiDi>
    <basicUdiDi>B-00857688007339</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede Flexible Programming Wand</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1004A-F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:28.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007322</udiDi>
    <basicUdiDi>B-00857688007322</basicUdiDi>
    <tradeName>remede</tradeName>
    <deviceName>remede Programming Wand</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1004A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:25.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007315</udiDi>
    <basicUdiDi>B-00857688007315</basicUdiDi>
    <tradeName>remede System</tradeName>
    <deviceName>remede Programmer</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1002A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:24.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007308</udiDi>
    <basicUdiDi>B-00857688007308</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7120-K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:23.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007292</udiDi>
    <basicUdiDi>B-00857688007292</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7090-K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:21.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007285</udiDi>
    <basicUdiDi>B-00857688007285</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7000-K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:19.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857688007278</udiDi>
    <basicUdiDi>B-00857688007278</basicUdiDi>
    <tradeName>Respiguide Delivery System</tradeName>
    <deviceName>Respiguide Delivery System</deviceName>
    <manufacturerName>ZOLL Respicardia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023953</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7120-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:17.811Z</lastUpdated>
  </row>
</eudamedExport>