<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>
  <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>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>
</eudamedExport>