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<eudamedExport entity="devices">
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    <udiDi>00859144004265</udiDi>
    <basicUdiDi>00859144004555JG</basicUdiDi>
    <tradeName>Barostim™ Carotid Sinus Lead</tradeName>
    <deviceName>Barostim™ Carotid Sinus Lead</deviceName>
    <manufacturerName>CVRx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001082</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J0209</emdnCode>
    <emdnDescription>CAROTID SINUS IMPLANTABLE NEUROSTIMULATORS AND LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100063-211</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:38:43.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859144004005</udiDi>
    <basicUdiDi>00859144004524J5</basicUdiDi>
    <tradeName>Barostim NEO™ Generator</tradeName>
    <deviceName>Barostim NEO™ Generator</deviceName>
    <manufacturerName>CVRx, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001082</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J0209</emdnCode>
    <emdnDescription>CAROTID SINUS IMPLANTABLE NEUROSTIMULATORS AND LEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100054-201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:38:39.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2112095166</udiDi>
    <basicUdiDi>B-2112095166</basicUdiDi>
    <tradeName>Atrostim PNS</tradeName>
    <deviceName>Atrostim Phrenic Nerve Stimulator</deviceName>
    <manufacturerName>Atrotech Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000015061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0206</emdnCode>
    <emdnDescription>FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>na</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:24.812Z</lastUpdated>
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    <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>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>
  <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>
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