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    <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>INT-105-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:23.002Z</lastUpdated>
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    <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>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-009-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <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>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-009-05</reference>
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    <lastUpdated>2026-07-29T17:58:21.115Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <udiDi>00841268104990</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-009-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.188Z</lastUpdated>
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    <udiDi>00841268105096</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-010-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.169Z</lastUpdated>
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    <udiDi>00841268105102</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-010-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.138Z</lastUpdated>
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    <udiDi>00841268105119</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-010-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.101Z</lastUpdated>
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    <udiDi>00841268105126</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-010-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.077Z</lastUpdated>
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    <udiDi>00841268105133</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-010-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.053Z</lastUpdated>
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    <udiDi>00841268105140</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-010-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:20.025Z</lastUpdated>
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    <udiDi>00841268105157</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-010-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.991Z</lastUpdated>
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    <udiDi>00841268105164</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-010-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.960Z</lastUpdated>
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    <udiDi>00841268105171</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-010-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.937Z</lastUpdated>
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    <udiDi>00841268105188</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>
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    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-010-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.897Z</lastUpdated>
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    <udiDi>00841268105195</udiDi>
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    <tradeName>Tearaway Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-010-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.838Z</lastUpdated>
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    <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>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-010-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.786Z</lastUpdated>
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    <udiDi>00841268105218</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-010-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.736Z</lastUpdated>
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    <udiDi>00841268105225</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-010-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:19.713Z</lastUpdated>
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