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<eudamedExport entity="devices">
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    <udiDi>10810005340431</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Belt, Curved, Extended</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>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9108-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:25:43.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340424</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Belt, Curved, Regular</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>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9108-R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:21:30.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340035</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Clinician Programmer</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>Sınıf III</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340059</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>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>Sınıf III</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340080</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>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>Sınıf III</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340134</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>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>Sınıf III</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020480</emdnCode>
    <emdnDescription>SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340141</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Tined Lead Kit</tradeName>
    <deviceName>Axonics Tined Lead</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>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340158</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>Tined Lead Kit with Percutaneous Extension</tradeName>
    <deviceName>Axonics Tined Lead (with Percutaneous Extension)</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>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-08T04:16:24.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340189</udiDi>
    <basicUdiDi>081000534AXNXZ8</basicUdiDi>
    <tradeName>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>Sınıf III</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>2026-08-08T04:16:24.329Z</lastUpdated>
  </row>
  <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>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>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>
</eudamedExport>