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    <tradeName>Introducer Sheath Sets</tradeName>
    <deviceName>Introducer Sheath Sets</deviceName>
    <manufacturerName>BrosMed Medical</manufacturerName>
    <manufacturerSrn>CN-PR-000048143</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <lastUpdated>2026-07-31T17:36:45.942Z</lastUpdated>
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    <tradeName>Braidin™ Pro Introducer Sheath</tradeName>
    <deviceName>Braidin™ Pro Introducer Sheath</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>92100651</reference>
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    <basicUdiDi>69318961INS152SE</basicUdiDi>
    <tradeName>Sereny™ Hemostasis Introducer</tradeName>
    <deviceName>Sereny™ Hemostasis Introducer</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
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    <reference>152A0415PA21T</reference>
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    <lastUpdated>2026-07-31T15:51:41.188Z</lastUpdated>
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    <tradeName>05391533180396</tradeName>
    <deviceName>PerQseal® Elite Introducer</deviceName>
    <manufacturerName>Vivasure Medical Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000000651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP4-FA1-2-G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:57:06.435Z</lastUpdated>
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    <basicUdiDi>539153318DP2FA1INTGDH</basicUdiDi>
    <tradeName>PerQseal</tradeName>
    <deviceName>PerQseal Introducer</deviceName>
    <manufacturerName>Vivasure Medical Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000000651</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DP2-FA1-5-G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:56:58.140Z</lastUpdated>
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    <udiDi>04260182521731</udiDi>
    <basicUdiDi>426018252ODSI7T</basicUdiDi>
    <tradeName>Occlutech Delivery Set</tradeName>
    <deviceName>Occlutech Delivery Set</deviceName>
    <manufacturerName>Occlutech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005104</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51DS007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:40:53.979Z</lastUpdated>
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    <udiDi>04251244503604</udiDi>
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    <tradeName>Fortress Introducer Sheath System</tradeName>
    <deviceName>Fortress Introducer Sheath System</deviceName>
    <manufacturerName>Contract Medical International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>358814</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:54:58.473Z</lastUpdated>
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    <tradeName>DuraSheath Introducer Sheath System</tradeName>
    <deviceName>DuraSheath Introducer Sheath System</deviceName>
    <manufacturerName>Contract Medical International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG-04045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:54:54.472Z</lastUpdated>
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    <udiDi>00810123710577</udiDi>
    <basicUdiDi>081012371ARTIXSH7W</basicUdiDi>
    <tradeName>Artix Thin-Walled Sheath, 90 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inari Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008693</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:33.776Z</lastUpdated>
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    <udiDi>00810123710560</udiDi>
    <basicUdiDi>081012371ARTIXSH7W</basicUdiDi>
    <tradeName>Artix Thin-Walled Sheath (65 cm)</tradeName>
    <deviceName>Artix Thin-Walled Sheath, 65 cm</deviceName>
    <manufacturerName>Inari Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008693</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-103</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:33.691Z</lastUpdated>
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    <udiDi>00850291007109</udiDi>
    <basicUdiDi>085029100750-101YZ</basicUdiDi>
    <tradeName>ClotTriever</tradeName>
    <deviceName>ClotTriever Sheath, 13 Fr</deviceName>
    <manufacturerName>Inari Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008693</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:32.857Z</lastUpdated>
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    <udiDi>00850291007123</udiDi>
    <basicUdiDi>085029100751-101ZC</basicUdiDi>
    <tradeName>ClotTriever Sheath</tradeName>
    <deviceName>ClotTriever Sheath, 16 Fr</deviceName>
    <manufacturerName>Inari Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008693</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:32.751Z</lastUpdated>
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    <udiDi>04035479176235</udiDi>
    <basicUdiDi>4035479BUDI00021PS</basicUdiDi>
    <tradeName>Selectra 3D-55-42</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOTRONIK SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>451790</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:28:27.263Z</lastUpdated>
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    <udiDi>00841268107052</udiDi>
    <basicUdiDi>08412681Galt-VTIR5</basicUdiDi>
    <tradeName>Galt VTI® Introducer Set</tradeName>
    <deviceName>Valved Tearaway Set Product Family</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>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTI-007-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:05.026Z</lastUpdated>
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    <udiDi>00841268103177</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Micro-Access Elite HV Catheter Introducer Set with Hemostasis Valve</tradeName>
    <deviceName>Cath-Lab Introducer Kit Product Family</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>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-100-04</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:56.218Z</lastUpdated>
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    <basicUdiDi>0827002CINC050-031_C1Y7</basicUdiDi>
    <tradeName>Flexor® Check-Flo®</tradeName>
    <deviceName>Flexor® Check-Flo® Introducer [Set, Raabe Modification,  Balkin Up &amp; Over® Contralateral Design]</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCFW-8.0-38-30-RB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:01:07.220Z</lastUpdated>
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    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName>Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Bare Mini Guidewire</deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000017793</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506516S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:51:56.203Z</lastUpdated>
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    <tradeName>AVANTI™+ Transradial Introducer Kit</tradeName>
    <deviceName>Catheter Sheath Introducer - AVANTI™+ Transradial Introducer Kit</deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504-614Z</reference>
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    <lastUpdated>2026-07-30T16:51:44.184Z</lastUpdated>
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    <tradeName>AVANTI™+ Catheter Sheath Introducer</tradeName>
    <deviceName>Catheter Sheath Introducer - AVANTI™+ Catheter Sheath Introducer</deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
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    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402-604P</reference>
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    <lastUpdated>2026-07-30T16:51:43.390Z</lastUpdated>
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    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Elite HV® 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>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-100-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:58:22.697Z</lastUpdated>
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