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    <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-127-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103900</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-127-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103917</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-127-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.309Z</lastUpdated>
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  <row>
    <udiDi>00841268103924</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-127-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.273Z</lastUpdated>
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  <row>
    <udiDi>00841268103931</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-127-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103948</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-127-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268103955</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-127-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104488</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>Tearaway 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-009-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104495</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>Tearaway 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-009-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104501</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>Tearaway 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-009-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104518</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>Tearaway 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-009-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104525</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-038-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104532</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-038-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:21.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104549</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-038-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104556</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-038-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104563</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-039-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.929Z</lastUpdated>
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  <row>
    <udiDi>00841268104570</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-039-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.886Z</lastUpdated>
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  <row>
    <udiDi>00841268104587</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-039-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268104594</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-039-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.821Z</lastUpdated>
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  <row>
    <udiDi>00841268104693</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-002-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.751Z</lastUpdated>
  </row>
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