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<eudamedExport entity="devices">
  <row>
    <udiDi>00841268105621</udiDi>
    <basicUdiDi>08412681Micro-KITSG</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-011-63</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105683</udiDi>
    <basicUdiDi>08412681Micro-KITSG</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-011-99</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105690</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-030-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105706</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-030-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105713</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-030-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105720</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-030-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105744</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-033-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105768</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-036-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105775</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-036-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105782</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-036-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105799</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-036-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105812</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-038-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105829</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-038-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105836</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-038-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105843</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-038-08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105898</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-038-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105935</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-038-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105942</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-038-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105959</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-038-19</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268105966</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-038-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:06.480Z</lastUpdated>
  </row>
</eudamedExport>