<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>00868643000470</udiDi>
    <basicUdiDi>086864300047CZ</basicUdiDi>
    <tradeName>IRRAflow Drainage Collection System</tradeName>
    <deviceName>IRRAflow Drainage Collection System</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCS 010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:01:00.844Z</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>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>
</eudamedExport>