<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760124131697</udiDi>
    <basicUdiDi>B-03760124131697</basicUdiDi>
    <tradeName>SiphonX® GRAVITATIONAL ANTI-SIPHON DEVICE</tradeName>
    <deviceName>SiphonX® GRAVITATIONAL ANTI-SIPHON DEVICE</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>SX-200</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:48.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131710</udiDi>
    <basicUdiDi>B-03760124131710</basicUdiDi>
    <tradeName>POLARIS® SPV ADJUSTABLE VALVE WITH ANTECHAMBER AND SiphonX®</tradeName>
    <deviceName>POLARIS® SPV ADJUSTABLE VALVE WITH ANTECHAMBER AND SiphonX®</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>SPVA-SX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:47.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131628</udiDi>
    <basicUdiDi>B-03760124131628</basicUdiDi>
    <tradeName>POLARIS® SPV-400 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>POLARIS® SPV-400 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>SPVA-400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:44.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131611</udiDi>
    <basicUdiDi>B-03760124131611</basicUdiDi>
    <tradeName>POLARIS® SPV-300 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>POLARIS® SPV-300 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>SPVA-300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:29.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131604</udiDi>
    <basicUdiDi>B-03760124131604</basicUdiDi>
    <tradeName>POLARIS® SPV-140 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>POLARIS® SPV-140 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>SPVA-140</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:28.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131581</udiDi>
    <basicUdiDi>B-03760124131581</basicUdiDi>
    <tradeName>DISPOSABLE HAND DRILL</tradeName>
    <deviceName>DISPOSABLE HAND DRILL</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P091304</emdnCode>
    <emdnDescription>CRANIAL PERFORATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-DR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:27.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131482</udiDi>
    <basicUdiDi>B-03760124131482</basicUdiDi>
    <tradeName>PRESSIO® MONITORING KIT, VENTRICULAR TUNNELING</tradeName>
    <deviceName>Pressio® Intracranial pressure monitoring Kit, ventricular tunnelling</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-VT</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:27.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131451</udiDi>
    <basicUdiDi>B-03760124131451</basicUdiDi>
    <tradeName>DISPOSABLE TUBULAR SHEATH FOR CATHETER PASSER 65 CM</tradeName>
    <deviceName>DISPOSABLE TUBULAR SHEATH FOR CATHETER PASSER 65 CM</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>TUG-65</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:23.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131444</udiDi>
    <basicUdiDi>B-03760124131444</basicUdiDi>
    <tradeName>DISPOSABLE TUBULAR SHEATH FOR CATHETER PASSER 45 CM</tradeName>
    <deviceName>DISPOSABLE TUBULAR SHEATH FOR CATHETER PASSER 45 CM</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>TUG-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:22.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131338</udiDi>
    <basicUdiDi>B-03760124131338</basicUdiDi>
    <tradeName>KIT POLARIS® SPVB PRECONNECTE / BO19-10</tradeName>
    <deviceName>POLARIS® SPVB 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>SPVB-2010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:21.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131321</udiDi>
    <basicUdiDi>B-03760124131321</basicUdiDi>
    <tradeName>VALVE AJUST. POLARIS® SPV / RES. TROU TREPAN</tradeName>
    <deviceName>POLARIS® SPV ADJUST. VALVE / BURR HOLE RES.</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>SPVB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:20.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131314</udiDi>
    <basicUdiDi>B-03760124131314</basicUdiDi>
    <tradeName>POLARIS® SPV-140 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>POLARIS® SPVA 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>SPVA-2010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:16.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131307</udiDi>
    <basicUdiDi>B-03760124131307</basicUdiDi>
    <tradeName>VALVE AJUSTABLE POLARIS® SPV / ANTICHAMBRE</tradeName>
    <deviceName>POLARIS® SPV 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>SPVA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:15.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131291</udiDi>
    <basicUdiDi>B-03760124131291</basicUdiDi>
    <tradeName>VALVE AJUSTABLE POLARIS® / 5 PRESS. 80-400</tradeName>
    <deviceName>POLARIS® ADJUSTABLE VALVE / 5 PRESS. 80-400</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-400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:15.017Z</lastUpdated>
  </row>
  <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>
</eudamedExport>