<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>20886333213690</udiDi>
    <basicUdiDi>B-20886333213690</basicUdiDi>
    <tradeName>One-Piece Catheter</tradeName>
    <deviceName>One-Piece Catheter Introducer</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>496150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:25:25.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333213058</udiDi>
    <basicUdiDi>B-20886333213058</basicUdiDi>
    <tradeName>Introducer</tradeName>
    <deviceName>Long Sheath Introducer</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>490027</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:25:22.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333007428</udiDi>
    <basicUdiDi>B-20886333007428</basicUdiDi>
    <tradeName>Guidewire Introducer Needles</tradeName>
    <deviceName>Winged Guidewire Introducer Needle</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGWI1802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:22:41.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333007411</udiDi>
    <basicUdiDi>B-20886333007411</basicUdiDi>
    <tradeName>Guidewire Introducer Needles</tradeName>
    <deviceName>Winged Guidewire Introducer Needle</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGWI1902</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:22:40.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004328</udiDi>
    <basicUdiDi>B-20886333004328</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391605400E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:54.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004311</udiDi>
    <basicUdiDi>B-20886333004311</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391605000E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:37.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004304</udiDi>
    <basicUdiDi>B-20886333004304</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391604500E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:35.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004298</udiDi>
    <basicUdiDi>B-20886333004298</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391604400E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:33.650Z</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>20886333004281</udiDi>
    <basicUdiDi>B-20886333004281</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391604300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:32.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004274</udiDi>
    <basicUdiDi>B-20886333004274</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391604000E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:31.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004267</udiDi>
    <basicUdiDi>B-20886333004267</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391605300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:28.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004250</udiDi>
    <basicUdiDi>B-20886333004250</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391505500E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:27.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004243</udiDi>
    <basicUdiDi>B-20886333004243</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391505400E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:26.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004236</udiDi>
    <basicUdiDi>B-20886333004236</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391505300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:24.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004229</udiDi>
    <basicUdiDi>B-20886333004229</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391505000E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:21.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004212</udiDi>
    <basicUdiDi>B-20886333004212</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391504500E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:20.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004205</udiDi>
    <basicUdiDi>B-20886333004205</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391504400E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:19.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>20886333004199</udiDi>
    <basicUdiDi>B-20886333004199</basicUdiDi>
    <tradeName>V-Stick Vascular Access Set</tradeName>
    <deviceName>V-Stick</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>MDD</legislation>
    <emdnCode>C058099</emdnCode>
    <emdnDescription>CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>391504300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:17:17.638Z</lastUpdated>
  </row>
</eudamedExport>