<?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>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>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>D-08680454742804TM</udiDi>
    <basicUdiDi>B-08680454742804TM</basicUdiDi>
    <tradeName>D-08680454742804TM</tradeName>
    <deviceName>Kateter sabitleme tap (Catheter Fixation Tap)</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038001</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES ADAPTERS AND CONNECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFT</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:28:32.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-08680454742798UK</udiDi>
    <basicUdiDi>B-08680454742798UK</basicUdiDi>
    <tradeName>D-08680454742798UK</tradeName>
    <deviceName>Polyprolene sağ açılı konnektör (Polyproplene Right Angle Connector)</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038001</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES ADAPTERS AND CONNECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPRAC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:28:31.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-08680454742781U2</udiDi>
    <basicUdiDi>B-08680454742781U2</basicUdiDi>
    <tradeName>D-08680454742781U2</tradeName>
    <deviceName>Polysulfon sağ açılı konnektör (Polysulphone Right Angle Connector)</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038001</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES ADAPTERS AND CONNECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSRAC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:28:28.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-08680454742774U5</udiDi>
    <basicUdiDi>B-08680454742774U5</basicUdiDi>
    <tradeName>D-08680454742774U5</tradeName>
    <deviceName>Polyproplene 3 yollu kateter konnektörü (Polyproplene 3-way Catheter Connector)</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038001</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES ADAPTERS AND CONNECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PP3WCCO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:28:27.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-08680454742767U8</udiDi>
    <basicUdiDi>B-08680454742767U8</basicUdiDi>
    <tradeName>D-08680454742767U8</tradeName>
    <deviceName>Polyproplene Kateter Konnektör (Polyproplene Catheter Connector)</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038001</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES ADAPTERS AND CONNECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPCCO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:28:23.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-08680454742750TP</udiDi>
    <basicUdiDi>B-08680454742750TP</basicUdiDi>
    <tradeName>D-08680454742750TP</tradeName>
    <deviceName>Titanyum kateter konektor (Titanium Catheter Connector)</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038001</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES ADAPTERS AND CONNECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCCO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:28:22.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-08680454742736TV</udiDi>
    <basicUdiDi>B-08680454742736TV</basicUdiDi>
    <tradeName>D-08680454742736TV</tradeName>
    <deviceName>0,46 mm 120 cm düz uçlu PTFE kaplı Guide wire (0,46 mm 120 cm Straight Tip PTFE Coated Guide Wire)</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038001</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES ADAPTERS AND CONNECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTFEGW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:28:21.365Z</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>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>
</eudamedExport>