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    <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>
    <reference>KIT-009-03</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:58.620Z</lastUpdated>
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    <basicUdiDi>08412681Tearaway-INTEC</basicUdiDi>
    <tradeName>Tearaway Introducer Set</tradeName>
    <deviceName>Tearaway Product Family</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:38.570Z</lastUpdated>
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    <basicUdiDi>08412681MSTearaway-INT67</basicUdiDi>
    <tradeName>MicroSlide® Introducer Set</tradeName>
    <deviceName>Pediatric Tearaway Introducer Set</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>
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    <reference>INT-101-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:34.573Z</lastUpdated>
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    <basicUdiDi>08412681MSTearaway-INT67</basicUdiDi>
    <tradeName>MicroSlide® Introducer Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-101-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:19.304Z</lastUpdated>
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    <udiDi>00841268101562</udiDi>
    <basicUdiDi>08412681MSTearaway-INT67</basicUdiDi>
    <tradeName>MicroSlide® 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>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-101-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:19.247Z</lastUpdated>
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    <udiDi>00841268101722</udiDi>
    <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>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:19.104Z</lastUpdated>
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    <udiDi>00841268101739</udiDi>
    <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-105-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.966Z</lastUpdated>
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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>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.888Z</lastUpdated>
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    <udiDi>00841268101753</udiDi>
    <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-105-08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.817Z</lastUpdated>
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    <udiDi>00841268101760</udiDi>
    <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-105-09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.752Z</lastUpdated>
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    <udiDi>00841268101791</udiDi>
    <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-105-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.694Z</lastUpdated>
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    <udiDi>00841268101807</udiDi>
    <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-105-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.633Z</lastUpdated>
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    <udiDi>00841268101814</udiDi>
    <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-105-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.571Z</lastUpdated>
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    <udiDi>00841268101821</udiDi>
    <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-105-19</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.506Z</lastUpdated>
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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>
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    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.438Z</lastUpdated>
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    <udiDi>00841268101845</udiDi>
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    <tradeName>Tearaway Introducer Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-25</reference>
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    <basicUdiDi>08412681Tearaway-INTEC</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-29</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:18.213Z</lastUpdated>
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    <tradeName>Tearaway Introducer Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>C0503</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-33</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:17.995Z</lastUpdated>
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    <tradeName>Tearaway Introducer Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
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    <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>INT-105-34</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T18:08:17.850Z</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-105-35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:23.846Z</lastUpdated>
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