<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>
  <row>
    <udiDi>03760124131017</udiDi>
    <basicUdiDi>B-03760124131017</basicUdiDi>
    <tradeName>SOPHY® SM1-M VALVE / ANTECHAMBER</tradeName>
    <deviceName>SOPHY® SM1-M 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>SM1A-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:27.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131000</udiDi>
    <basicUdiDi>B-03760124131000</basicUdiDi>
    <tradeName>SOPHY® SM1-L VALVE / ANTECHAMBER</tradeName>
    <deviceName>SOPHY® SM1-L 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>SM1A-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:26.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130997</udiDi>
    <basicUdiDi>B-03760124130997</basicUdiDi>
    <tradeName>SOPHY® SM1-H VALVE / ANTECHAMBER</tradeName>
    <deviceName>SOPHY® SM1-H 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>SM1A-H</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:25.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130980</udiDi>
    <basicUdiDi>B-03760124130980</basicUdiDi>
    <tradeName>SOPHY® SM1-M KIT PREATTACHED/ BO19-10</tradeName>
    <deviceName>SOPHY® SM1-M 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>SM1-2010M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:23.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130973</udiDi>
    <basicUdiDi>B-03760124130973</basicUdiDi>
    <tradeName>SOPHY® SM1-L KIT PREATTACHED/ BO19-10</tradeName>
    <deviceName>SOPHY® SM1-L 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>SM1-2010L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:21.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130966</udiDi>
    <basicUdiDi>B-03760124130966</basicUdiDi>
    <tradeName>SOPHY® SM1-H KIT PREATTACHED/ BO19-10</tradeName>
    <deviceName>SOPHY® SM1-H 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>SM1-2010H</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:19.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130669</udiDi>
    <basicUdiDi>B-03760124130669</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 8 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 8 cm</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>PRO8</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:14.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130652</udiDi>
    <basicUdiDi>B-03760124130652</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 7 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 7 cm</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>PRO7</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:13.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130645</udiDi>
    <basicUdiDi>B-03760124130645</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 6 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 6 cm</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>PRO6</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:12.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130638</udiDi>
    <basicUdiDi>B-03760124130638</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 5 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 5 cm</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>PRO5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:10.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130621</udiDi>
    <basicUdiDi>B-03760124130621</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 4 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 4 cm</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>PRO4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:08.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130614</udiDi>
    <basicUdiDi>B-03760124130614</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 3 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 3 cm</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>PRO3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:06.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130607</udiDi>
    <basicUdiDi>B-03760124130607</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 12 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 12 cm</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>PRO12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:06.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130591</udiDi>
    <basicUdiDi>B-03760124130591</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 11 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 11 cm</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>PRO11</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:04.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130584</udiDi>
    <basicUdiDi>B-03760124130584</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV. 10 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 10 cm</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>PRO10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:02.135Z</lastUpdated>
  </row>
</eudamedExport>