<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760124131192</udiDi>
    <basicUdiDi>B-03760124131192</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® MINI/ 8 PRESS. 80-400</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 80-400</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>SM8-400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:27.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131185</udiDi>
    <basicUdiDi>B-03760124131185</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® MINI/ 8 PRESS. 50-300</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 50-30</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>SM8-300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:26.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124132359</udiDi>
    <basicUdiDi>B-03760124132359</basicUdiDi>
    <tradeName>POLARIS® 24 ADJUSTABLE VALVE</tradeName>
    <deviceName>POLARIS® 24 ADJUSTABLE VALVE</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>SPV24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:19.154Z</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>
</eudamedExport>