<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760124130300</udiDi>
    <basicUdiDi>B-03760124130300</basicUdiDi>
    <tradeName>LUMBO-PERITONEAL SET</tradeName>
    <deviceName>LUMBO-PERITONEAL CATHETER KIT</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N020102</emdnCode>
    <emdnDescription>SUBARACHNOID SPINAL CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPS50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:46.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130379</udiDi>
    <basicUdiDi>B-03760124130379</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE COUDE RESERV./PECT. 12 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir / pectoral 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>PLO12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:45.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130270</udiDi>
    <basicUdiDi>B-03760124130270</basicUdiDi>
    <tradeName>REPLACEMENT DRAINAGE BAG II</tradeName>
    <deviceName>Replacement Drainage Bag II</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060399</emdnCode>
    <emdnDescription>FLUID COLLECTION BAGS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-420</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:42.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130263</udiDi>
    <basicUdiDi>B-03760124130263</basicUdiDi>
    <tradeName>CSF MONITORING AND DRAINAGE SYSTEM</tradeName>
    <deviceName>External Drainage and CSF Monitoring System</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060399</emdnCode>
    <emdnDescription>FLUID COLLECTION BAGS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-410</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:27.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130232</udiDi>
    <basicUdiDi>B-03760124130232</basicUdiDi>
    <tradeName>REPLACEMENT DRAINAGE BAG</tradeName>
    <deviceName>Replacement Drainage Bag</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060399</emdnCode>
    <emdnDescription>FLUID COLLECTION BAGS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-220</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:26.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130225</udiDi>
    <basicUdiDi>B-03760124130225</basicUdiDi>
    <tradeName>EXTERNAL NEUROLOGICAL DRAINAGE SYSTEM</tradeName>
    <deviceName>External Neurological Drainage System</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060399</emdnCode>
    <emdnDescription>FLUID COLLECTION BAGS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-210</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:26.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130218</udiDi>
    <basicUdiDi>B-03760124130218</basicUdiDi>
    <tradeName>EXTERNAL LUMBAR CATHETER WITH INTRODUCER GUIDE</tradeName>
    <deviceName>External Lumbar Catheter With Introducer Guide</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-109</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:25.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130201</udiDi>
    <basicUdiDi>B-03760124130201</basicUdiDi>
    <tradeName>EXTERNAL LUMBAR CATHETER</tradeName>
    <deviceName>External Lumbar Catheter</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-108</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:21.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130195</udiDi>
    <basicUdiDi>B-03760124130195</basicUdiDi>
    <tradeName>EXTERNAL VENTRICULAR CATHETER</tradeName>
    <deviceName>External Ventricular Catheter</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-106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:20.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130140</udiDi>
    <basicUdiDi>B-03760124130140</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE COUDE 9 CM</tradeName>
    <deviceName>Right angle ventricular catheter reservoir 9 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>BO90</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:19.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130133</udiDi>
    <basicUdiDi>B-03760124130133</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE COUDE 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>BO80</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:18.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130126</udiDi>
    <basicUdiDi>B-03760124130126</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE COUDE 7 CM</tradeName>
    <deviceName>Right angle ventricular catheter 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>BO70</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:14.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130119</udiDi>
    <basicUdiDi>B-03760124130119</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE COUDE 6 CM</tradeName>
    <deviceName>Right angle ventricular catheter 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>BO60</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:14.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130102</udiDi>
    <basicUdiDi>B-03760124130102</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE COUDE 5 CM</tradeName>
    <deviceName>Right angle ventricular catheter 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>BO50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:13.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130096</udiDi>
    <basicUdiDi>B-03760124130096</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE COUDE 4 CM</tradeName>
    <deviceName>Right angle ventricular catheter 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>BO40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:12.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130034</udiDi>
    <basicUdiDi>B-03760124130034</basicUdiDi>
    <tradeName>CATHETER PERITONEAL ANTI-REFLUX</tradeName>
    <deviceName>Antireflux peritoneal catheter</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>B905S-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:08.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130010</udiDi>
    <basicUdiDi>B-03760124130010</basicUdiDi>
    <tradeName>CATHETER DISTAL ATRIAL/PERITONEAL</tradeName>
    <deviceName>Distal atrial / peritoneal catheter</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>B905S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:07.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760409441411</udiDi>
    <basicUdiDi>376012413PSOMPA000B8</basicUdiDi>
    <tradeName>PRESSIO® 3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3,5mm</tradeName>
    <deviceName>PRESSIO 3 - ANALOG BLOOD PRESSURE CABLE</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-MPA01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:20:31.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124132403</udiDi>
    <basicUdiDi>376012413PAK001UX</basicUdiDi>
    <tradeName>POLARIS® VALVES ELECTRONIC READING INSTRUMENT</tradeName>
    <deviceName>POLARIS® ELECTRONIC READING INSTRUMENT</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>N0199</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAK3-ERI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:14:57.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124132007</udiDi>
    <basicUdiDi>376012413PSOMRI000DN</basicUdiDi>
    <tradeName>PRESSIO® MRI SUPPORT</tradeName>
    <deviceName>PRESSIO MRI SUPPORT</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059099</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-MRI</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:14:57.069Z</lastUpdated>
  </row>
</eudamedExport>