<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05391530910033</udiDi>
    <basicUdiDi>B-05391530910033</basicUdiDi>
    <tradeName>pRESET Thrombectomy Device</tradeName>
    <deviceName>pRESET Thrombectomy Device</deviceName>
    <manufacturerName>phenox Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000011333</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010404020401</emdnCode>
    <emdnDescription>MANUAL NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IE102063001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:47:42.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391530910026</udiDi>
    <basicUdiDi>B-05391530910026</basicUdiDi>
    <tradeName>pRESET Thrombectomy Device</tradeName>
    <deviceName>pRESET Thrombectomy Device</deviceName>
    <manufacturerName>phenox Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000011333</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010404020401</emdnCode>
    <emdnDescription>MANUAL NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IE102042001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:47:41.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391530910118</udiDi>
    <basicUdiDi>B-05391530910118</basicUdiDi>
    <tradeName>pRESET LITE Thrombectomy Device</tradeName>
    <deviceName>pRESET LITE Thrombectomy Device</deviceName>
    <manufacturerName>phenox Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000011333</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010404020401</emdnCode>
    <emdnDescription>MANUAL NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IE102042011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:47:40.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391530910088</udiDi>
    <basicUdiDi>B-05391530910088</basicUdiDi>
    <tradeName>pRESET LITE Thrombectomy Device</tradeName>
    <deviceName>pRESET LITE Thrombectomy Device</deviceName>
    <manufacturerName>phenox Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000011333</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010404020401</emdnCode>
    <emdnDescription>MANUAL NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IE102032011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:47:38.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260638513570</udiDi>
    <basicUdiDi>B-04260638513570</basicUdiDi>
    <tradeName>VentrEX® EVD-System</tradeName>
    <deviceName>VentrEX® EVD System</deviceName>
    <manufacturerName>Neuromedex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005867</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>57-00121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:31:29.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131246</udiDi>
    <basicUdiDi>B-03760124131246</basicUdiDi>
    <tradeName>SOPHY® SM8B KIT PREATTACHED / BO19-10</tradeName>
    <deviceName>SOPHY® SM8B 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>SM8B-2010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:31.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131192</udiDi>
    <basicUdiDi>B-03760124131192</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® MINI/ 8 PRESS. 80-400</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 80-400</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>SM8-400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:27.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131185</udiDi>
    <basicUdiDi>B-03760124131185</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® MINI/ 8 PRESS. 50-300</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 50-30</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>SM8-300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:26.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131239</udiDi>
    <basicUdiDi>B-03760124131239</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® SM8 / RESERVOIR TROU TREPAN</tradeName>
    <deviceName>SOPHY® SM8 ADJUSTABLE 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>SM8B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:26.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131208</udiDi>
    <basicUdiDi>B-03760124131208</basicUdiDi>
    <tradeName>KIT SOPHY® SM8-400 PRECONNECTE/ BO19-10</tradeName>
    <deviceName>8KIT SOPHY® SM8-400 PRECONNECTE/ 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>SM8-400-2010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:25.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131178</udiDi>
    <basicUdiDi>B-03760124131178</basicUdiDi>
    <tradeName>KIT SOPHY® SM8 LOMBO-PERITONEAL PRECONNECTE</tradeName>
    <deviceName>LUMBO-PERITONEAL 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>SM8-2040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:08.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130072</udiDi>
    <basicUdiDi>B-03760124130072</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE DROIT GRADUE 1.3 x 2.2</tradeName>
    <deviceName>Graduated straight ventricular catheter 1.3 x 2.2</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>BO19-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:07.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130065</udiDi>
    <basicUdiDi>B-03760124130065</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE DROIT STANDARD 1.3 x 2.5</tradeName>
    <deviceName>Standard straight ventricular catheter 1.3 x 2.5</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>BO19-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:06.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130041</udiDi>
    <basicUdiDi>B-03760124130041</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE DROIT PEDIATRIQUE 1.3 x 2.2</tradeName>
    <deviceName>Paediatric straight ventricular catheter 1.3 x 2.2</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>BO15</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:06.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701675312616</udiDi>
    <basicUdiDi>B-03701675312616</basicUdiDi>
    <tradeName>Protecteur Clovis Vincent A</tradeName>
    <deviceName>Protecteur Clovis Vincent A</deviceName>
    <manufacturerName>Ets Claude LASSERTEUX S.A</manufacturerName>
    <manufacturerSrn>FR-MF-000001821</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L11050301</emdnCode>
    <emdnDescription>CEREBRAL SPREADERS AND RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795007.13</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:10:47.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701675312609</udiDi>
    <basicUdiDi>B-03701675312609</basicUdiDi>
    <tradeName>Protecteur Clovis Vincent B</tradeName>
    <deviceName>Protecteur Clovis Vincent B</deviceName>
    <manufacturerName>Ets Claude LASSERTEUX S.A</manufacturerName>
    <manufacturerSrn>FR-MF-000001821</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L11050301</emdnCode>
    <emdnDescription>CEREBRAL SPREADERS AND RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795007.14</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:10:45.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701675312593</udiDi>
    <basicUdiDi>B-03701675312593</basicUdiDi>
    <tradeName>Protecteur Clovis Vincent B coudé</tradeName>
    <deviceName>Protecteur Clovis Vincent B coudé</deviceName>
    <manufacturerName>Ets Claude LASSERTEUX S.A</manufacturerName>
    <manufacturerSrn>FR-MF-000001821</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L11050301</emdnCode>
    <emdnDescription>CEREBRAL SPREADERS AND RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795007.15</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:10:44.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701675312586</udiDi>
    <basicUdiDi>B-03701675312586</basicUdiDi>
    <tradeName>Protecteur Clovis Vincent C</tradeName>
    <deviceName>Protecteur Clovis Vincent C</deviceName>
    <manufacturerName>Ets Claude LASSERTEUX S.A</manufacturerName>
    <manufacturerSrn>FR-MF-000001821</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L11050301</emdnCode>
    <emdnDescription>CEREBRAL SPREADERS AND RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795007.16</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:10:42.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701675312579</udiDi>
    <basicUdiDi>B-03701675312579</basicUdiDi>
    <tradeName>Protecteur Clovis Vincent L</tradeName>
    <deviceName>Protecteur Clovis Vincent L</deviceName>
    <manufacturerName>Ets Claude LASSERTEUX S.A</manufacturerName>
    <manufacturerSrn>FR-MF-000001821</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L11050301</emdnCode>
    <emdnDescription>CEREBRAL SPREADERS AND RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795007.22</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:10:40.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701675312562</udiDi>
    <basicUdiDi>B-03701675312562</basicUdiDi>
    <tradeName>Protecteur Clovis Vincent F</tradeName>
    <deviceName>Protecteur Clovis Vincent F</deviceName>
    <manufacturerName>Ets Claude LASSERTEUX S.A</manufacturerName>
    <manufacturerSrn>FR-MF-000001821</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L11050301</emdnCode>
    <emdnDescription>CEREBRAL SPREADERS AND RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795007.29</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:10:38.934Z</lastUpdated>
  </row>
</eudamedExport>