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<eudamedExport entity="devices">
  <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>
  <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>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>
</eudamedExport>