<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760124131284</udiDi>
    <basicUdiDi>B-03760124131284</basicUdiDi>
    <tradeName>VALVE AJUSTABLE POLARIS® / 5 PRESS. 50-300</tradeName>
    <deviceName>Polaris® adjustable valve / 5 press. 50-300</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPV-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:14.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131277</udiDi>
    <basicUdiDi>B-03760124131277</basicUdiDi>
    <tradeName>KIT POLARIS® SPV PRECONNECTE / BO19-10</tradeName>
    <deviceName>Polaris ® SPV kit preattached/ BO19-10</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPV-2010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:10.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131260</udiDi>
    <basicUdiDi>B-03760124131260</basicUdiDi>
    <tradeName>POLARIS® SPV-140 ADJUSTABLE VALVE</tradeName>
    <deviceName>Polaris® adjustable valve / 5 press. 10-140</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPV-140</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:09.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131253</udiDi>
    <basicUdiDi>B-03760124131253</basicUdiDi>
    <tradeName>POLARIS® SPV ADJUSTABLE VALVE</tradeName>
    <deviceName>Polaris® adjustable valve / 5 press.</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPV</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:08.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131222</udiDi>
    <basicUdiDi>B-03760124131222</basicUdiDi>
    <tradeName>SOPHY® SM8A KIT PREATTACHED / BO19-10</tradeName>
    <deviceName>SOPHY® SM8A KIT PREATTACHED / BO19-10</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8A-2010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:07.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131215</udiDi>
    <basicUdiDi>B-03760124131215</basicUdiDi>
    <tradeName>SOPHY® SM8 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>SOPHY® SM8 ADJUSTABLE VALVE/ ANTECHAMBER</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:03.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131161</udiDi>
    <basicUdiDi>B-03760124131161</basicUdiDi>
    <tradeName>SOPHY® SM8 KIT PREATTACHED/ PLO7</tradeName>
    <deviceName>SOPHY® SM8 KIT PREATTACHED/ PLO7</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2031</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:03.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131154</udiDi>
    <basicUdiDi>B-03760124131154</basicUdiDi>
    <tradeName>SOPHY® SM8 KIT PREATTACHED/ PLO6</tradeName>
    <deviceName>SOPHY® SM8 KIT PREATTACHED/ PLO6</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:02.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131147</udiDi>
    <basicUdiDi>B-03760124131147</basicUdiDi>
    <tradeName>SOPHY® SM8 KIT PREATTACHED/ PRO7</tradeName>
    <deviceName>SOPHY® SM8 KIT PREATTACHED/ PRO7</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2021</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:01.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131130</udiDi>
    <basicUdiDi>B-03760124131130</basicUdiDi>
    <tradeName>SOPHY® SM8 KIT PREATTACHED/ PRO6</tradeName>
    <deviceName>SOPHY® SM8 KIT PREATTACHED/ PRO6</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:57.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131123</udiDi>
    <basicUdiDi>B-03760124131123</basicUdiDi>
    <tradeName>SOPHY® SM8 KIT PREATTACHED/ BO19-10</tradeName>
    <deviceName>SOPHY® SM8 KIT PREATTACHED/ BO19-10</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:56.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131116</udiDi>
    <basicUdiDi>B-03760124131116</basicUdiDi>
    <tradeName>SOPHY® SM8 KIT PREATTACHED</tradeName>
    <deviceName>SOPHY® SM8 KIT PREATTACHED</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:55.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131109</udiDi>
    <basicUdiDi>B-03760124131109</basicUdiDi>
    <tradeName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 10-140</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 10-140</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038002</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICE VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-140</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:55.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131093</udiDi>
    <basicUdiDi>B-03760124131093</basicUdiDi>
    <tradeName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESSURE</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038002</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICE VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:50.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131079</udiDi>
    <basicUdiDi>B-03760124131079</basicUdiDi>
    <tradeName>SOPHY® MINI MONOPRESS. VALVE MP</tradeName>
    <deviceName>SOPHY® MINI MONOPRESS. VALVE MP</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038002</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICE VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM1-M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:50.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131062</udiDi>
    <basicUdiDi>B-03760124131062</basicUdiDi>
    <tradeName>SOPHY® MINI MONOPRESS. VALVE LP</tradeName>
    <deviceName>SOPHY® MINI MONOPRESS. VALVE LP</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038002</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICE VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM1-L</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:49.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131055</udiDi>
    <basicUdiDi>B-03760124131055</basicUdiDi>
    <tradeName>SOPHY® MINI MONOPRESS. VALVE HP</tradeName>
    <deviceName>SOPHY® MINI MONOPRESS. VALVE HP</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038002</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICE VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM1-H</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:48.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131024</udiDi>
    <basicUdiDi>B-03760124131024</basicUdiDi>
    <tradeName>SOPHY® SM1-H VALVE / BURR HOLE RESERVOIR</tradeName>
    <deviceName>SOPHY® SM1-H VALVE / BURR HOLE RESERVOIR</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM1B-H</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:44.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131048</udiDi>
    <basicUdiDi>B-03760124131048</basicUdiDi>
    <tradeName>SOPHY® SM1-M VALVE / BURR HOLE RESERVOIR</tradeName>
    <deviceName>SOPHY® SM1-M VALVE /BURR HOLE RESERVOIR</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM1B-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:43.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131031</udiDi>
    <basicUdiDi>B-03760124131031</basicUdiDi>
    <tradeName>SOPHY® SM1-L VALVE / BURR HOLE RESERVOIR</tradeName>
    <deviceName>SOPHY® SM1-L VALVE / BURR HOLE RESERVOIR</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM1B-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:43.108Z</lastUpdated>
  </row>
</eudamedExport>