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<eudamedExport entity="devices">
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    <basicUdiDi>07050320000000000000011C6</basicUdiDi>
    <tradeName>AVANTI™+ Transradial Introducer Kit</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>504-617Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:26.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032010283</udiDi>
    <basicUdiDi>07050320000000000000011C6</basicUdiDi>
    <tradeName>AVANTI™+ Transradial Introducer Kit</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>504-616Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:26.401Z</lastUpdated>
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  <row>
    <udiDi>04251244503826</udiDi>
    <basicUdiDi>4251244500000113F</basicUdiDi>
    <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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>452387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:08:58.490Z</lastUpdated>
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  <row>
    <udiDi>04251244503192</udiDi>
    <basicUdiDi>4251244500000013C</basicUdiDi>
    <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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG-05090-F-LIMA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:08:57.695Z</lastUpdated>
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  <row>
    <udiDi>20886333227598</udiDi>
    <basicUdiDi>08863333600012E</basicUdiDi>
    <tradeName>Intara</tradeName>
    <deviceName>Intara Introducer Sheath</deviceName>
    <manufacturerName>Argon Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002324</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>ISD10040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:36:52.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850291007604</udiDi>
    <basicUdiDi>0850291007CT9Y</basicUdiDi>
    <tradeName>ClotTriever Sheath</tradeName>
    <deviceName>ClotTriever Sheath 16Fr</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>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:00.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850291007260</udiDi>
    <basicUdiDi>085029100752-101ZP</basicUdiDi>
    <tradeName>Intri24 Introducer Sheath</tradeName>
    <deviceName>Intri24 Introducer Sheat</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>52-101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:31:58.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002299818</udiDi>
    <basicUdiDi>0827002CINC050-031_C2Y9</basicUdiDi>
    <tradeName>Flexor® Check-Flo®</tradeName>
    <deviceName>Flexor® : Check-Flo® Introducer [Ansel Modification, Ansel [1] Modification - with High-Flex Dilator and Hydrophilic Coating, Balkin Up &amp; Over® Contralateral Design, with -HC] ; Touhy-Borst Side-Arm Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCFW-5.0-18/38-45-RB-ANL1-HC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:37.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002103849</udiDi>
    <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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCFW-7.0-38-40-RB-BLKN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:03.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902194425</udiDi>
    <basicUdiDi>08019020000000000000103K3</basicUdiDi>
    <tradeName>Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters</tradeName>
    <deviceName>Multi-Lumen Access Catheter (MAC) &amp; Percutaneous Sheath Introducer (PSI) Product</deviceName>
    <manufacturerName>Arrow International LLC (Subsidiary of Teleflex Incorporated)</manufacturerName>
    <manufacturerSrn>US-MF-000024256</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CI-09800-SB</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:23:45.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032082099</udiDi>
    <basicUdiDi>07050320000000000000069D5</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName>Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Nitinol 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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506716N</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:32:43.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032082051</udiDi>
    <basicUdiDi>07050320000000000000068D3</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName>Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Polymer 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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506716P20G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:32:42.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884908169300</udiDi>
    <basicUdiDi>00884908313MZ</basicUdiDi>
    <tradeName>Medcomp Valved Peelable Introducers</tradeName>
    <deviceName>Medcomp/Jet Valved Peelable Introducers</deviceName>
    <manufacturerName>Medical Components, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008230</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MR190703</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:03.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032009904</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>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504-604P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:33.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705032010276</udiDi>
    <basicUdiDi>07050320000000000000011C6</basicUdiDi>
    <tradeName>AVANTI™+ Transradial Introducer Kit</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>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504-615Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:32.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401098</udiDi>
    <basicUdiDi>B-18904314401098</basicUdiDi>
    <tradeName>Introducer Sheath Kit</tradeName>
    <deviceName>AD-DUCER Introducer Sheath Kit</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATIS 7F-07-025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:47.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401081</udiDi>
    <basicUdiDi>B-18904314401081</basicUdiDi>
    <tradeName>Introducer Sheath Kit</tradeName>
    <deviceName>AD-DUCER Introducer Sheath Kit</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATIS 6F-07-025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:45.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401074</udiDi>
    <basicUdiDi>B-18904314401074</basicUdiDi>
    <tradeName>Introducer Sheath Kit</tradeName>
    <deviceName>AD-DUCER Introducer Sheath Kit</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATIS 5F-07-025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:44.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401067</udiDi>
    <basicUdiDi>B-18904314401067</basicUdiDi>
    <tradeName>Introducer Sheath Kit</tradeName>
    <deviceName>AD-DUCER Introducer Sheath Kit</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATIS 4F-07-025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:43.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401050</udiDi>
    <basicUdiDi>B-18904314401050</basicUdiDi>
    <tradeName>Introducer Sheath Kit</tradeName>
    <deviceName>AD-DUCER Introducer Sheath Kit</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARIS 7F-07-025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:40.730Z</lastUpdated>
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</eudamedExport>