<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10810005340158</udiDi>
    <basicUdiDi>B-10810005340158</basicUdiDi>
    <tradeName>Axonics Tined Lead (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>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:12.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810005340141</udiDi>
    <basicUdiDi>B-10810005340141</basicUdiDi>
    <tradeName>Axonics Tined Lead</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>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:10.918Z</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>10810005340127</udiDi>
    <basicUdiDi>B-10810005340127</basicUdiDi>
    <tradeName>Axonics PNE Lead</tradeName>
    <deviceName>Axonics PNE Lead</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>J020403</emdnCode>
    <emdnDescription>SACRAL SPINE NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:15:06.103Z</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>10810005340066</udiDi>
    <basicUdiDi>B-10810005340066</basicUdiDi>
    <tradeName>Axonics Neurostimulator</tradeName>
    <deviceName>Axonics Neurostimulator</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>J020402</emdnCode>
    <emdnDescription>INTESTINAL INCONTINENCE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:59.750Z</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>
  <row>
    <udiDi>09352307000735</udiDi>
    <basicUdiDi>B-09352307000735</basicUdiDi>
    <tradeName>Evoke® Charger (AU)</tradeName>
    <deviceName>Evoke® Charger (AU)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:16.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000421</udiDi>
    <basicUdiDi>B-09352307000421</basicUdiDi>
    <tradeName>Evoke® Charger (UK)</tradeName>
    <deviceName>Evoke® Charger (UK)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:14.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000261</udiDi>
    <basicUdiDi>B-09352307000261</basicUdiDi>
    <tradeName>Evoke® Lead Adapter Kit</tradeName>
    <deviceName>Evoke® Lead Adapter Kit</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:13.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000216</udiDi>
    <basicUdiDi>B-09352307000216</basicUdiDi>
    <tradeName>Evoke® External Closed Loop Stimulator (eCLS)</tradeName>
    <deviceName>Evoke® External Closed Loop Stimulator (eCLS)</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020299</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:12.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000209</udiDi>
    <basicUdiDi>B-09352307000209</basicUdiDi>
    <tradeName>Evoke® 12C Trial Percutaneous Lead Kit - 90cm</tradeName>
    <deviceName>Evoke® 12C Trial Percutaneous Lead Kit - 90cm</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020203</emdnCode>
    <emdnDescription>SPINAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:09.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000186</udiDi>
    <basicUdiDi>B-09352307000186</basicUdiDi>
    <tradeName>Evoke® 12C Trial Percutaneous Lead Kit - 60cm</tradeName>
    <deviceName>Evoke® 12C Trial Percutaneous Lead Kit - 60cm</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020203</emdnCode>
    <emdnDescription>SPINAL NEUROSTIMULATION LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:08.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000162</udiDi>
    <basicUdiDi>B-09352307000162</basicUdiDi>
    <tradeName>Evoke® Spares Kit</tradeName>
    <deviceName>Evoke® Spares Kit</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:07.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000148</udiDi>
    <basicUdiDi>B-09352307000148</basicUdiDi>
    <tradeName>Evoke® Epidural Needle, 6.5”</tradeName>
    <deviceName>Evoke® Epidural Needle, 6.5”</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:05.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000124</udiDi>
    <basicUdiDi>B-09352307000124</basicUdiDi>
    <tradeName>Evoke® Tunnelling Tool</tradeName>
    <deviceName>Evoke® Tunnelling Tool</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:03.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000117</udiDi>
    <basicUdiDi>B-09352307000117</basicUdiDi>
    <tradeName>Evoke® 12C Lead Extension Kit - 55cm</tradeName>
    <deviceName>Evoke® 12C Lead Extension Kit - 55cm</deviceName>
    <manufacturerName>Saluda Medical Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000010522</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J020280</emdnCode>
    <emdnDescription>SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:01.747Z</lastUpdated>
  </row>
</eudamedExport>