<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260125713841</udiDi>
    <basicUdiDi>426012571MON1ST4Q</basicUdiDi>
    <tradeName>Pressure Monitor</tradeName>
    <deviceName>Pressure Monitor</deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MON.1.00.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:20.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125713810</udiDi>
    <basicUdiDi>426012571ICP3STXM</basicUdiDi>
    <tradeName>Parenchymal Probe 4F</tradeName>
    <deviceName>Parenchymal Probe</deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.3.04.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:19.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683955400129</udiDi>
    <basicUdiDi>B-08683955400129</basicUdiDi>
    <tradeName>KIBO</tradeName>
    <deviceName>KIBO Ventriküler Kafa İçi Basınç Ölçüm Cihazı / KIBO Ventricular Intracranial Pressure Measurement Device</deviceName>
    <manufacturerName>LİNACOL MEDİKAL A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000033766</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KICP-001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:29:22.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124132076</udiDi>
    <basicUdiDi>B-03760124132076</basicUdiDi>
    <tradeName>PRESSIO® 2 ICP MONITOR</tradeName>
    <deviceName>Pressio 2 ICP Monitor</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-4000</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:32:16.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131772</udiDi>
    <basicUdiDi>B-03760124131772</basicUdiDi>
    <tradeName>PRESSIO® ICP &amp; ICT MONITORING KIT, VENTRICULAR TUNNELING</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, VENTRICULAR TUNNELING</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-VTT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:59.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131765</udiDi>
    <basicUdiDi>B-03760124131765</basicUdiDi>
    <tradeName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL WITH BOLT</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL TUNNELING</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PTT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:57.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131758</udiDi>
    <basicUdiDi>B-03760124131758</basicUdiDi>
    <tradeName>KIT PRESSIO® POUR MONITORING DE PRESSION ET DE TEMPÉRATURE INTRACRÂNIENNES, PARENCHYMATEUX À BOULON</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL WITH BOLT</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PBT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:55.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131482</udiDi>
    <basicUdiDi>B-03760124131482</basicUdiDi>
    <tradeName>PRESSIO® MONITORING KIT, VENTRICULAR TUNNELING</tradeName>
    <deviceName>Pressio® Intracranial pressure monitoring Kit, ventricular tunnelling</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-VT</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:27.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130782</udiDi>
    <basicUdiDi>B-03760124130782</basicUdiDi>
    <tradeName>PRESSIO® MONITORING KIT, PARENCHYMAL TUNNELING</tradeName>
    <deviceName>Pressio® Intracranial pressure monitoring Kit, parenchymal tunnelling</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PT</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:18.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130768</udiDi>
    <basicUdiDi>B-03760124130768</basicUdiDi>
    <tradeName>PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT</tradeName>
    <deviceName>Pressio® Intracranial pressure monitoring Kit, parenchymal with bolt</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:17.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125713827</udiDi>
    <basicUdiDi>426012571ICP3STXM</basicUdiDi>
    <tradeName>Parenchymal Probe 4F with tunneling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.3.04.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T15:14:48.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125713834</udiDi>
    <basicUdiDi>426012571ICP3STXM</basicUdiDi>
    <tradeName>Parenchymal Probe 4F with Cranial Bolt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.3.04.03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T15:14:48.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125714039</udiDi>
    <basicUdiDi>426012571ICP1STXB</basicUdiDi>
    <tradeName>Ventricular Probe 9F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.1.09.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:50:01.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125713766</udiDi>
    <basicUdiDi>426012571ICP1STXB</basicUdiDi>
    <tradeName>Ventricular Probe 10F with tunneling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.1.10.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:51.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125713759</udiDi>
    <basicUdiDi>426012571ICP1STXB</basicUdiDi>
    <tradeName>Ventricular Probe 10F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.1.10.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:50.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125713735</udiDi>
    <basicUdiDi>426012571ICP1STXB</basicUdiDi>
    <tradeName>Ventricular Probe 8F with tunneling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.1.08.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:49.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125712905</udiDi>
    <basicUdiDi>B-04260125712905</basicUdiDi>
    <tradeName>Silverline® Ventricular Probe with Cranial Bolt 8F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SND13.1.14S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:40.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125712561</udiDi>
    <basicUdiDi>B-04260125712561</basicUdiDi>
    <tradeName>Silverline® Ventricular Probe 10F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SND13.1.15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:37.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125712554</udiDi>
    <basicUdiDi>B-04260125712554</basicUdiDi>
    <tradeName>Silverline® Ventricular Probe 8F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SND13.1.14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:36.198Z</lastUpdated>
  </row>
</eudamedExport>