<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760124130041</udiDi>
    <basicUdiDi>B-03760124130041</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE DROIT PEDIATRIQUE 1.3 x 2.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BO15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:21.882Z</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>03760124132076</udiDi>
    <basicUdiDi>B-03760124132076</basicUdiDi>
    <tradeName>PRESSIO® 2 ICP MONITOR</tradeName>
    <deviceName>Pressio 2 ICP Monitor</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-4000</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:16.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124132052</udiDi>
    <basicUdiDi>B-03760124132052</basicUdiDi>
    <tradeName>POLARIS® 24 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>POLARIS® 24 SPV24A 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>SPV24A-2010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:15.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124132045</udiDi>
    <basicUdiDi>B-03760124132045</basicUdiDi>
    <tradeName>POLARIS® 24 SPV24 KIT PREATTACHED / BO19-10</tradeName>
    <deviceName>POLARIS® 24 SPV24 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>SPV24-2010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:14.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124132014</udiDi>
    <basicUdiDi>B-03760124132014</basicUdiDi>
    <tradeName>POLARIS® 24 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>POLARIS® 24 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>SPV24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:12.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131925</udiDi>
    <basicUdiDi>B-03760124131925</basicUdiDi>
    <tradeName>SOPHY® SM1A-L KIT PREATTACHED / BO19-10</tradeName>
    <deviceName>SOPHY® SM1A-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>SM1A-2010L</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:10.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131918</udiDi>
    <basicUdiDi>B-03760124131918</basicUdiDi>
    <tradeName>SOPHY® SM1A-M KIT PREATTACHED / BO19-10</tradeName>
    <deviceName>SOPHY® SM1A-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>SM1A-2010M</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:08.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131901</udiDi>
    <basicUdiDi>B-03760124131901</basicUdiDi>
    <tradeName>SOPHY® SM1A-H KIT PREATTACHED / BO19-10</tradeName>
    <deviceName>SOPHY® SM1A-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>SM1A-2010H</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:07.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131871</udiDi>
    <basicUdiDi>B-03760124131871</basicUdiDi>
    <tradeName>KUBALA EXTERNAL VENTRICULAR CATHETER (LARGE LUMEN)</tradeName>
    <deviceName>External Ventricular Catheter (Large Lumen)</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:06.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131864</udiDi>
    <basicUdiDi>B-03760124131864</basicUdiDi>
    <tradeName>CATHETER PASSER DISPOSABLE, 65 CM + SHEATH</tradeName>
    <deviceName>CATHETER PASSER DISPOSABLE, 65 CM + SHEATH</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N02800208</emdnCode>
    <emdnDescription>SPINAL DEVICES TUNNELISERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUD-65</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:03.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131857</udiDi>
    <basicUdiDi>B-03760124131857</basicUdiDi>
    <tradeName>CATHETER PASSER DISPOSABLE, 45 CM + SHEATH</tradeName>
    <deviceName>CATHETER PASSER DISPOSABLE, 45 CM + SHEATH</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N02800208</emdnCode>
    <emdnDescription>SPINAL DEVICES TUNNELISERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUD-45</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:02.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131840</udiDi>
    <basicUdiDi>B-03760124131840</basicUdiDi>
    <tradeName>CATHETER PASSER DISPOSABLE, 30 CM + SHEATH</tradeName>
    <deviceName>CATHETER PASSER DISPOSABLE, 30 CM + SHEATH</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N02800208</emdnCode>
    <emdnDescription>SPINAL DEVICES TUNNELISERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUD-30</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:01.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131772</udiDi>
    <basicUdiDi>B-03760124131772</basicUdiDi>
    <tradeName>PRESSIO® ICP &amp; ICT MONITORING KIT, VENTRICULAR TUNNELING</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, VENTRICULAR TUNNELING</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-VTT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:59.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131765</udiDi>
    <basicUdiDi>B-03760124131765</basicUdiDi>
    <tradeName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL WITH BOLT</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL TUNNELING</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-PTT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:57.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131758</udiDi>
    <basicUdiDi>B-03760124131758</basicUdiDi>
    <tradeName>KIT PRESSIO® POUR MONITORING DE PRESSION ET DE TEMPÉRATURE INTRACRÂNIENNES, PARENCHYMATEUX À BOULON</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL WITH BOLT</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-PBT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:55.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131741</udiDi>
    <basicUdiDi>B-03760124131741</basicUdiDi>
    <tradeName>POLARIS® SPV-140 ADJUSTABLE VALVE / ANTECHAMBER</tradeName>
    <deviceName>POLARIS® ADJUSTABLE VALVE 10-140 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-140-SX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:55.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131734</udiDi>
    <basicUdiDi>B-03760124131734</basicUdiDi>
    <tradeName>POLARIS® ADJUSTABLE VALVE 10-140 WITH SiphonX®</tradeName>
    <deviceName>Polaris® adjustable valve 10-140 with 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>SPV-140-SX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:53.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131727</udiDi>
    <basicUdiDi>B-03760124131727</basicUdiDi>
    <tradeName>POLARIS® ADJUSTABLE VALVE 30-200 WITH BURR HOLE RESERVOIR AND SiphonX®</tradeName>
    <deviceName>POLARIS® ADJUSTABLE VALVE 30-200 WITH BURR HOLE RESERVOIR 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>SPVB-SX</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:51.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131703</udiDi>
    <basicUdiDi>B-03760124131703</basicUdiDi>
    <tradeName>POLARIS® ADJUSTABLE VALVE 30-200 WITH SiphonX®</tradeName>
    <deviceName>POLARIS® ADJUSTABLE VALVE 30-200 WITH 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>SPV-SX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:49.485Z</lastUpdated>
  </row>
</eudamedExport>