<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00841268105980</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-039-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106055</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-039-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106062</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-039-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106086</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-039-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106093</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-039-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106109</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-039-19</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106123</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106130</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106147</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106154</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106161</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106178</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106185</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106192</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106208</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106215</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>MicroSlide® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-051-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106857</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-010-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106987</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>GaltStick® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-037-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268106994</udiDi>
    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>GaltStick® Introducer Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0501</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-037-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268107069</udiDi>
    <basicUdiDi>08412681Galt-VTIR5</basicUdiDi>
    <tradeName>Galt VTI® Introducer Set</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTI-007-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:05.928Z</lastUpdated>
  </row>
</eudamedExport>