<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09352307000094</udiDi>
    <basicUdiDi>B-09352307000094</basicUdiDi>
    <tradeName>Evoke® 12C Percutaneous Lead Kit - 90cm</tradeName>
    <deviceName>Evoke® 12C 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>1009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:50:00.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000070</udiDi>
    <basicUdiDi>B-09352307000070</basicUdiDi>
    <tradeName>Evoke® 12C Percutaneous Lead Kit - 60cm</tradeName>
    <deviceName>Evoke® 12C 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>1008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:59.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000018</udiDi>
    <basicUdiDi>B-09352307000018</basicUdiDi>
    <tradeName>Evoke®  Pocket Console (EPC)</tradeName>
    <deviceName>Evoke® Pocket Console (EPC)</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>1003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:57.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000056</udiDi>
    <basicUdiDi>B-09352307000056</basicUdiDi>
    <tradeName>Evoke® Charger (EU)</tradeName>
    <deviceName>Evoke® Charger (EU)</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>1006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:55.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000032</udiDi>
    <basicUdiDi>B-09352307000032</basicUdiDi>
    <tradeName>Evoke® Clinical System Transceiver (CST)</tradeName>
    <deviceName>Evoke® Clinical System Transceiver (CST)</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>J020701</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:55.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352307000001</udiDi>
    <basicUdiDi>B-09352307000001</basicUdiDi>
    <tradeName>Evoke® Closed-Loop Stimulator (CLS)</tradeName>
    <deviceName>Evoke® Closed Loop Stimulator (CLS)</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>J02020201</emdnCode>
    <emdnDescription>FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:53.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760136</udiDi>
    <basicUdiDi>B-07640183760136</basicUdiDi>
    <tradeName>directSTIM Port Plug</tradeName>
    <deviceName>Port Plug</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>J020180</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:52.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760129</udiDi>
    <basicUdiDi>B-07640183760129</basicUdiDi>
    <tradeName>directSTIM Power Cord</tradeName>
    <deviceName>Power Cord</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>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:37.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760112</udiDi>
    <basicUdiDi>B-07640183760112</basicUdiDi>
    <tradeName>directSTIM Adjustable Harness</tradeName>
    <deviceName>Adjustable Harness</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>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:36.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760105</udiDi>
    <basicUdiDi>B-07640183760105</basicUdiDi>
    <tradeName>directSTIM Charging Paddle</tradeName>
    <deviceName>Charging Paddle</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>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:35.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760099</udiDi>
    <basicUdiDi>B-07640183760099</basicUdiDi>
    <tradeName>directSTIM Magnet</tradeName>
    <deviceName>Magnet</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>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:35.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760082</udiDi>
    <basicUdiDi>B-07640183760082</basicUdiDi>
    <tradeName>directSTIM Tunneling Tool</tradeName>
    <deviceName>Tunneling tool</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>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:31.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760075</udiDi>
    <basicUdiDi>B-07640183760075</basicUdiDi>
    <tradeName>directSTIM Trial Cable</tradeName>
    <deviceName>Trial Cable</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>J020780</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:30.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760068</udiDi>
    <basicUdiDi>B-07640183760068</basicUdiDi>
    <tradeName>directSTIM External Pulse Generator</tradeName>
    <deviceName>directSTIM External 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>J020199</emdnCode>
    <emdnDescription>CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:29.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760051</udiDi>
    <basicUdiDi>B-07640183760051</basicUdiDi>
    <tradeName>directSTIM Patient Programmer Charger kit</tradeName>
    <deviceName>directSTIM Patient Programmer Charger 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>J020701</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:28.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640183760044</udiDi>
    <basicUdiDi>B-07640183760044</basicUdiDi>
    <tradeName>directSTIM Clinician Programmer</tradeName>
    <deviceName>directSTIM Clinician Programmer</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>J020701</emdnCode>
    <emdnDescription>NEUROSTIMULATORS PROGRAMMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:49:24.436Z</lastUpdated>
  </row>
  <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>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>
</eudamedExport>