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<eudamedExport entity="devices">
  <row>
    <udiDi>10810005340196</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Foramen Needle, Long</tradeName>
    <deviceName>Axonics Accessory, Foramen Needle - Long</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340219</udiDi>
    <basicUdiDi>B-10810005340219</basicUdiDi>
    <tradeName>Axonics Accessory, Stimulation Ground Cable</tradeName>
    <deviceName>Axonics Accessory, Stimulation Ground Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340226</udiDi>
    <basicUdiDi>B-10810005340226</basicUdiDi>
    <tradeName>Axonics Accessory, Torque Wrench</tradeName>
    <deviceName>Axonics Accessory, Torque Wrench</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340233</udiDi>
    <basicUdiDi>B-10810005340233</basicUdiDi>
    <tradeName>Axonics Accessory, Charging System Adhesive Carriers</tradeName>
    <deviceName>Axonics Accessory, Charging System Adhesive Carriers</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340240</udiDi>
    <basicUdiDi>B-10810005340240</basicUdiDi>
    <tradeName>Axonics Accessory, J-Clip Stimulation Cable</tradeName>
    <deviceName>Axonics Accessory, J-Clip Stimulation Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340257</udiDi>
    <basicUdiDi>B-10810005340257</basicUdiDi>
    <tradeName>Axonics Accessory, Lead Stimulation Cable</tradeName>
    <deviceName>Axonics Accessory, Lead Stimulation Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340264</udiDi>
    <basicUdiDi>B-10810005340264</basicUdiDi>
    <tradeName>Axonics Accessory, Charging Belt - Regular Size</tradeName>
    <deviceName>Axonics Accessory, Charging Belt - Regular Size</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9008-R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:23.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340271</udiDi>
    <basicUdiDi>B-10810005340271</basicUdiDi>
    <tradeName>Axonics Accessory, Charging Belt - Extended Size</tradeName>
    <deviceName>Axonics Accessory, Charging Belt - Extended Size</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9008-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:23.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340288</udiDi>
    <basicUdiDi>B-10810005340288</basicUdiDi>
    <tradeName>Axonics Accessory, Lead Extension Cable</tradeName>
    <deviceName>Axonics Accessory, Lead Extension Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:23.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340301</udiDi>
    <basicUdiDi>B-10810005340301</basicUdiDi>
    <tradeName>Axonics Accessory Dilator and Sheath</tradeName>
    <deviceName>Axonics Accessory Dilator and Sheath</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:23.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340318</udiDi>
    <basicUdiDi>B-10810005340318</basicUdiDi>
    <tradeName>Axonics Accessory Tunneling Tool and Directional Guide</tradeName>
    <deviceName>Axonics Accessory Tunneling Tool and Directional Guide</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:23.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340325</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Basic Trial Cable</tradeName>
    <deviceName>Axonics Accessory, Basic Trial Cable</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:23.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340462</udiDi>
    <basicUdiDi>B-10810005340462</basicUdiDi>
    <tradeName>Axonics Accessory Tunneling Tool</tradeName>
    <deviceName>Axonics Accessory Tunneling Tool</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:23.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000478087</udiDi>
    <basicUdiDi>B-00763000478087</basicUdiDi>
    <tradeName>Vanta™  AdaptiveStim™</tradeName>
    <deviceName>Vanta INS</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>J02020202</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORSS, NOT RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>977006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:07:18.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000426484</udiDi>
    <basicUdiDi>B-00763000426484</basicUdiDi>
    <tradeName>SenSight™</tradeName>
    <deviceName>Sensight™ Extension Kit</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>J020180</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B3400060M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:07:17.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>00643169781719</udiDi>
    <basicUdiDi>B-00643169781719</basicUdiDi>
    <tradeName>Intellis™ AdaptiveStim®</tradeName>
    <deviceName>Implantable Spinal Neurostimulator</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>J02020201</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97715</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:07:07.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340455</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Neurostimulator, Rechargeable-Free</tradeName>
    <deviceName>Axonics Sacral Neuromodulation System</deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020402</emdnCode>
    <emdnDescription>INTESTINAL INCONTINENCE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T12:43:58.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340479</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Neurostimulator, Rechargeable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Axonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008413</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020402</emdnCode>
    <emdnDescription>INTESTINAL INCONTINENCE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:47:02.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>00199309000757</udiDi>
    <basicUdiDi>0763000B00009588S</basicUdiDi>
    <tradeName>N/A</tradeName>
    <deviceName>Communicator</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>TM90Q0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:54:18.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00199150016594</udiDi>
    <basicUdiDi>0763000B00002106T</basicUdiDi>
    <tradeName>N/A</tradeName>
    <deviceName>Communicator</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>TM91D0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:54:11.793Z</lastUpdated>
  </row>
</eudamedExport>