<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760124130218</udiDi>
    <basicUdiDi>B-03760124130218</basicUdiDi>
    <tradeName>EXTERNAL LUMBAR CATHETER WITH INTRODUCER GUIDE</tradeName>
    <deviceName>External Lumbar Catheter With Introducer Guide</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-109</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:25.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130201</udiDi>
    <basicUdiDi>B-03760124130201</basicUdiDi>
    <tradeName>EXTERNAL LUMBAR CATHETER</tradeName>
    <deviceName>External Lumbar Catheter</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-108</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:21.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130195</udiDi>
    <basicUdiDi>B-03760124130195</basicUdiDi>
    <tradeName>EXTERNAL VENTRICULAR CATHETER</tradeName>
    <deviceName>External Ventricular Catheter</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:29:20.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>00868643000432</udiDi>
    <basicUdiDi>B-00868643000432</basicUdiDi>
    <tradeName>IRRAflow Catheter 2.0</tradeName>
    <deviceName>IRRAflow Catheter 2.0</deviceName>
    <manufacturerName>IRRAS USA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011820</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICGS 020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:52.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00868643000418</udiDi>
    <basicUdiDi>B-00868643000418</basicUdiDi>
    <tradeName>IRRAflow Tube Set</tradeName>
    <deviceName>IRRAflow Tube Set</deviceName>
    <manufacturerName>IRRAS USA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011820</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICDS 020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:50.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125713025</udiDi>
    <basicUdiDi>B-04260125713025</basicUdiDi>
    <tradeName>Silverline® Ventricular Drainage Catheter with Cranial Bolt 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>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.034.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:44.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125710307</udiDi>
    <basicUdiDi>B-04260125710307</basicUdiDi>
    <tradeName>Silverline® Ventricular Drainage Catheter 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>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.030.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:33.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125710246</udiDi>
    <basicUdiDi>B-04260125710246</basicUdiDi>
    <tradeName>Silverline® Ventricular Drainage Catheter 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>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.014.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:31.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125710161</udiDi>
    <basicUdiDi>B-04260125710161</basicUdiDi>
    <tradeName>External Ventricular Drainage Set with Plate and Clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.004.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:29.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260125710116</udiDi>
    <basicUdiDi>B-04260125710116</basicUdiDi>
    <tradeName>External Ventricular Drainage Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.001.01/FV800P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:28.098Z</lastUpdated>
  </row>
</eudamedExport>