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<eudamedExport entity="devices">
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    <udiDi>10886333223760</udiDi>
    <basicUdiDi>B-10886333223760</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access 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>497865</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:20.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333223753</udiDi>
    <basicUdiDi>B-10886333223753</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access 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>497821</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:18.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333223746</udiDi>
    <basicUdiDi>B-10886333223746</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access 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>497841</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:17.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333223739</udiDi>
    <basicUdiDi>B-10886333223739</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access</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>497854</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:15.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333223722</udiDi>
    <basicUdiDi>B-10886333223722</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access 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>497866</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:12.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333223715</udiDi>
    <basicUdiDi>B-10886333223715</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access 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>497857</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:11.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333223692</udiDi>
    <basicUdiDi>B-10886333223692</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access 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>497852</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:10.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333223685</udiDi>
    <basicUdiDi>B-10886333223685</basicUdiDi>
    <tradeName>OneStic Micro-Access</tradeName>
    <deviceName>OneStic Micro-Access 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>497831</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:08.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333214294</udiDi>
    <basicUdiDi>B-10886333214294</basicUdiDi>
    <tradeName>Hemostasis Valve</tradeName>
    <deviceName>Hemostasis Valve</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>497296</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:04.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213747</udiDi>
    <basicUdiDi>B-10886333213747</basicUdiDi>
    <tradeName>One Piece Introducer</tradeName>
    <deviceName>One Piece Introducer Kit</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>496155</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:04.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333214300</udiDi>
    <basicUdiDi>B-10886333214300</basicUdiDi>
    <tradeName>Hemostasis Valve</tradeName>
    <deviceName>Hemostasis Valve</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>497297</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:46:01.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213730</udiDi>
    <basicUdiDi>B-10886333213730</basicUdiDi>
    <tradeName>One-Piece Introducer</tradeName>
    <deviceName>One-Piece Introducer Kit</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>496154</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:47.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213723</udiDi>
    <basicUdiDi>B-10886333213723</basicUdiDi>
    <tradeName>One-Piece Introducer Kit</tradeName>
    <deviceName>One-Piece Introducer Kit</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>496153</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:43.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213716</udiDi>
    <basicUdiDi>B-10886333213716</basicUdiDi>
    <tradeName>One-Piece</tradeName>
    <deviceName>One-Piece Introducer Kit</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>496152</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:42.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213709</udiDi>
    <basicUdiDi>B-10886333213709</basicUdiDi>
    <tradeName>One-Piece Introducer</tradeName>
    <deviceName>One-Piece Introducer Kit</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>496151</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:41.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213631</udiDi>
    <basicUdiDi>B-10886333213631</basicUdiDi>
    <tradeName>One Piece/Tuohy-Borst</tradeName>
    <deviceName>One Piece/Tuohy-Borst 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>496136</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:40.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213624</udiDi>
    <basicUdiDi>B-10886333213624</basicUdiDi>
    <tradeName>One Piece/Tuohy-Borst Catheter</tradeName>
    <deviceName>One Piece/Tuohy-Borst 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>496135</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:36.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213617</udiDi>
    <basicUdiDi>B-10886333213617</basicUdiDi>
    <tradeName>One Piece/Tuohy-Borst</tradeName>
    <deviceName>One Piece/Tuohy-Borst 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>496134</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:35.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213600</udiDi>
    <basicUdiDi>B-10886333213600</basicUdiDi>
    <tradeName>One Piece/Tuohy-Borst</tradeName>
    <deviceName>One Piece/Tuohy-Borst 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>496133</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:35.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333213594</udiDi>
    <basicUdiDi>B-10886333213594</basicUdiDi>
    <tradeName>One Piece/Tuohy-Borst</tradeName>
    <deviceName>One Piece/Tuohy-Borst 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>496132</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:33.497Z</lastUpdated>
  </row>
</eudamedExport>