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<eudamedExport entity="devices">
  <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>2026-07-11T00:15:47.776Z</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>2026-07-11T00:15:46.968Z</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>2026-07-11T00:15:45.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340325</udiDi>
    <basicUdiDi>B-10810005340325</basicUdiDi>
    <tradeName>Axonics Accessory, 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>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:44.680Z</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>2026-07-11T00:15:27.715Z</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>2026-07-11T00:15:26.921Z</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>2026-07-11T00:15:26.112Z</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>2026-07-11T00:15:25.419Z</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>2026-07-11T00:15:21.878Z</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>2026-07-11T00:15:20.515Z</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>2026-07-11T00:15:20.234Z</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>2026-07-11T00:15:19.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340196</udiDi>
    <basicUdiDi>B-10810005340196</basicUdiDi>
    <tradeName>Axonics Accessory, 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>AIMDD</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>2026-07-11T00:15:13.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340189</udiDi>
    <basicUdiDi>B-10810005340189</basicUdiDi>
    <tradeName>Axonics Accessory, Foramen Needle - Short</tradeName>
    <deviceName>Axonics Accessory, Foramen Needle - Short</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>9001-S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:12.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340134</udiDi>
    <basicUdiDi>B-10810005340134</basicUdiDi>
    <tradeName>Axonics PNE Lead Implant Kit</tradeName>
    <deviceName>Axonics PNE Lead Implant Kit</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>1701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:07.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340103</udiDi>
    <basicUdiDi>B-10810005340103</basicUdiDi>
    <tradeName>Axonics Remote Control</tradeName>
    <deviceName>Axonics Remote Control</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>2301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:04.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340080</udiDi>
    <basicUdiDi>B-10810005340080</basicUdiDi>
    <tradeName>Axonics Lead Implant Kit</tradeName>
    <deviceName>Axonics Lead Implant Kit</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>1801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:03.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340059</udiDi>
    <basicUdiDi>B-10810005340059</basicUdiDi>
    <tradeName>Axonics Trial Stimulator</tradeName>
    <deviceName>Axonics Trial Stimulator</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>1601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:58.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340035</udiDi>
    <basicUdiDi>B-10810005340035</basicUdiDi>
    <tradeName>Axonics Clinician Programmer (EPG/IPG)</tradeName>
    <deviceName>Axonics Clinician Programmer (EPG/IPG)</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>2501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:58.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340011</udiDi>
    <basicUdiDi>B-10810005340011</basicUdiDi>
    <tradeName>Axonics Charging System</tradeName>
    <deviceName>Axonics Charging System</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>1401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:57.355Z</lastUpdated>
  </row>
</eudamedExport>