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    <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-099-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:23.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268110021</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-099-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:23.357Z</lastUpdated>
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  <row>
    <udiDi>00841268110038</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-099-19</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:23.277Z</lastUpdated>
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    <udiDi>10705032078917</udiDi>
    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506510S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T09:17:30.500Z</lastUpdated>
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  <row>
    <udiDi>10705032078931</udiDi>
    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506416S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T09:17:30.463Z</lastUpdated>
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  <row>
    <udiDi>10705032078948</udiDi>
    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506610S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T09:17:30.431Z</lastUpdated>
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  <row>
    <udiDi>10705032078955</udiDi>
    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506710S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T09:17:30.374Z</lastUpdated>
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  <row>
    <udiDi>10705032078986</udiDi>
    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506716S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T09:17:30.339Z</lastUpdated>
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  <row>
    <udiDi>10705032079006</udiDi>
    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506616S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T09:17:30.289Z</lastUpdated>
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  <row>
    <udiDi>10705032079044</udiDi>
    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506410S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T09:17:30.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032076913</udiDi>
    <basicUdiDi>07050320000000000000009CK</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW7VBTH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032076890</udiDi>
    <basicUdiDi>07050320000000000000009CK</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW6VBTH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032076876</udiDi>
    <basicUdiDi>07050320000000000000009CK</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW6ADTH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.925Z</lastUpdated>
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  <row>
    <udiDi>10705032076852</udiDi>
    <basicUdiDi>07050320000000000000009CK</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW5VBTH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.898Z</lastUpdated>
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  <row>
    <udiDi>10705032076920</udiDi>
    <basicUdiDi>07050320000000000000054CQ</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW7VBTB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.759Z</lastUpdated>
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  <row>
    <udiDi>10705032076906</udiDi>
    <basicUdiDi>07050320000000000000054CQ</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW6VBTB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.739Z</lastUpdated>
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    <udiDi>10705032076883</udiDi>
    <basicUdiDi>07050320000000000000054CQ</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW6ADTB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.685Z</lastUpdated>
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  <row>
    <udiDi>10705032076869</udiDi>
    <basicUdiDi>07050320000000000000054CQ</basicUdiDi>
    <tradeName>RAILWAY Sheathless Access System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RW5VBTB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:31.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032000642</udiDi>
    <basicUdiDi>07050320000000000000010C4</basicUdiDi>
    <tradeName>AVANTI™+ Catheter Sheath Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402-607P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:28.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032000659</udiDi>
    <basicUdiDi>07050320000000000000010C4</basicUdiDi>
    <tradeName>AVANTI™+ Catheter Sheath Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402-607R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:27.846Z</lastUpdated>
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