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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>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-102-41</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:25.140Z</lastUpdated>
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    <udiDi>00841268109490</udiDi>
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    <tradeName>Elite HV® F 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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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Elite HV® F 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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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Elite HV® F 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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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-113-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00841268109520</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® F 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-114-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00841268109537</udiDi>
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    <tradeName>Elite HV® F 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-114-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:25.027Z</lastUpdated>
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    <udiDi>00841268109544</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® F 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-114-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00841268109551</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® F 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-115-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00841268109568</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® F 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-115-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:24.873Z</lastUpdated>
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    <udiDi>00841268109575</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® F 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-115-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:24.849Z</lastUpdated>
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    <udiDi>00841268109582</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® F 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-115-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:24.816Z</lastUpdated>
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    <udiDi>00841268109612</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-096-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:24.776Z</lastUpdated>
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    <basicUdiDi>08412681Tearaway-INTEC</basicUdiDi>
    <tradeName>Tearaway 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>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-128-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:24.461Z</lastUpdated>
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    <udiDi>00841268109735</udiDi>
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    <tradeName>Tearaway 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>
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    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:24.421Z</lastUpdated>
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    <udiDi>00841268109742</udiDi>
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    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00841268109759</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-128-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00841268109803</udiDi>
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    <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-098-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:24.198Z</lastUpdated>
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