<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00841268103634</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-121-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:22.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103641</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-122-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:22.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103658</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-122-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:22.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103665</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-122-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103672</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-122-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103689</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-123-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103696</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-123-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103702</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-123-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103719</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-123-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103726</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-124-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103733</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-124-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103740</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-124-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103757</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-124-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103764</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-125-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103771</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-125-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103788</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-125-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103795</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® MB 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-125-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103801</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-126-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103818</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-126-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103825</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® T 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-126-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.598Z</lastUpdated>
  </row>
</eudamedExport>