<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00845225003647</udiDi>
    <basicUdiDi>08452250BM40773</basicUdiDi>
    <tradeName>Phoenix Guidewire, Floppy Tip, Light Support</tradeName>
    <deviceName>Phoenix Guidewire</deviceName>
    <manufacturerName>Philips Image Guided Therapy Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000018632</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG14300LF</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:07:53.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225003227</udiDi>
    <basicUdiDi>08452250BM37177</basicUdiDi>
    <tradeName>Visions PV .014P RX Digital IVUS Catheter</tradeName>
    <deviceName>Visions PV</deviceName>
    <manufacturerName>Philips Image Guided Therapy Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000018632</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104020102</emdnCode>
    <emdnDescription>INTRAVASCULAR ULTRASOUND CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:07:49.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108448</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName>ELITE HV Hydrophilic Radial</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-132-06</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:09.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268107694</udiDi>
    <basicUdiDi>08412681GaltVIT-KITHY</basicUdiDi>
    <tradeName>Galt VTI® Introducer Kit</tradeName>
    <deviceName>Valved Tearaway Introducer Kit With Sideport</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-077-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:07.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268107236</udiDi>
    <basicUdiDi>08412681ACL-HV6H</basicUdiDi>
    <tradeName>Gateway HV® Valved Adapter</tradeName>
    <deviceName>Attachable Cath Lab Hemostasis</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GWT-000-30</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:06.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268107052</udiDi>
    <basicUdiDi>08412681Galt-VTIR5</basicUdiDi>
    <tradeName>Galt VTI® Introducer Set</tradeName>
    <deviceName>Valved Tearaway Set Product Family</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTI-007-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:05.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268107045</udiDi>
    <basicUdiDi>08412681SterileDilatorCM</basicUdiDi>
    <tradeName>Dilator</tradeName>
    <deviceName>Dilator</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C9002</emdnCode>
    <emdnDescription>VASCULAR AND FASCIAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIL-615-52</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:02.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104617</udiDi>
    <basicUdiDi>08412681Micro-KITSG</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName>Micro Introducer Kits</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-002-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:00.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104471</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>Tearaway Introducer Kit</tradeName>
    <deviceName>Tearaway Introducer Kit</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-009-03</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:58.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103177</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Micro-Access Elite HV Catheter Introducer Set with Hemostasis Valve</tradeName>
    <deviceName>Cath-Lab Introducer Kit Product Family</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-100-04</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:56.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268101715</udiDi>
    <basicUdiDi>08412681Tearaway-INTEC</basicUdiDi>
    <tradeName>Tearaway Introducer Set</tradeName>
    <deviceName>Tearaway Product Family</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:38.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268101548</udiDi>
    <basicUdiDi>08412681MSTearaway-INT67</basicUdiDi>
    <tradeName>MicroSlide® Introducer Set</tradeName>
    <deviceName>Pediatric Tearaway Introducer Set</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-101-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:34.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268101531</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>GaltStick® Introducer Set</tradeName>
    <deviceName>Galtstick Introducer Kit</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-036-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:33.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268100619</udiDi>
    <basicUdiDi>08412681Guidewires&lt;90cm2K</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>Guidewires with a Maximum Length of 90cm</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020199</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES- OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGW-015-14</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:32.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840828196321</udiDi>
    <basicUdiDi>084082819631AD</basicUdiDi>
    <tradeName>SURE-LOCK Electrode Clip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Curbell Medical Products, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002618</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30623</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:20.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840828187374</udiDi>
    <basicUdiDi>084082818737AP</basicUdiDi>
    <tradeName>SURE-LOCK Electrode Clip</tradeName>
    <deviceName>SURE LOCK, ASSEMBLY, A34, BLUE LEVER</deviceName>
    <manufacturerName>Curbell Medical Products, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002618</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27759</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:19.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840828187367</udiDi>
    <basicUdiDi>084082818736AM</basicUdiDi>
    <tradeName>SURE-LOCK Electrode Clip</tradeName>
    <deviceName>SURE LOCK, ASSEMBLY, A34, GREEN LEVER</deviceName>
    <manufacturerName>Curbell Medical Products, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002618</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27758</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:15.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840828187350</udiDi>
    <basicUdiDi>084082818735AK</basicUdiDi>
    <tradeName>SURE-LOCK Electrode Clip</tradeName>
    <deviceName>SURE LOCK, ASSEMBLY, A34, ORANGE LEVER</deviceName>
    <manufacturerName>Curbell Medical Products, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002618</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27757</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:14.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840828187343</udiDi>
    <basicUdiDi>084082818734AH</basicUdiDi>
    <tradeName>SURE-LOCK Electrode Clip</tradeName>
    <deviceName>SURE LOCK, ASSEMBLY, A34, RED LEVER</deviceName>
    <manufacturerName>Curbell Medical Products, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002618</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27756</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:13.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840828185943</udiDi>
    <basicUdiDi>084082818594AR</basicUdiDi>
    <tradeName>SURE-LOCK Electrode Clip</tradeName>
    <deviceName>SURE-LOCK Electrode Clip</deviceName>
    <manufacturerName>Curbell Medical Products, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002618</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27685</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:12.956Z</lastUpdated>
  </row>
</eudamedExport>