<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10886333208415</udiDi>
    <basicUdiDi>B-10886333208415</basicUdiDi>
    <tradeName>Needle</tradeName>
    <deviceName>AMC/4 Arterial 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>195318</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:06.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333208408</udiDi>
    <basicUdiDi>B-10886333208408</basicUdiDi>
    <tradeName>Needle</tradeName>
    <deviceName>AMC/4 Arterial 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>195317</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:01.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333208385</udiDi>
    <basicUdiDi>B-10886333208385</basicUdiDi>
    <tradeName>Needle</tradeName>
    <deviceName>AMC/3 Arterial 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>195312</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:45:00.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>10886333208378</udiDi>
    <basicUdiDi>B-10886333208378</basicUdiDi>
    <tradeName>Needle</tradeName>
    <deviceName>AMC/3 Arterial 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>195311</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:44:45.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210651</udiDi>
    <basicUdiDi>B-10801902210651</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-07711</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:12.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210569</udiDi>
    <basicUdiDi>B-10801902210569</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH-LAB SHEATH INTRO SET:</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-07911</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:11.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210552</udiDi>
    <basicUdiDi>B-10801902210552</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-07611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:07.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210545</udiDi>
    <basicUdiDi>B-10801902210545</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .021" - .025" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-07511-P</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:06.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210538</udiDi>
    <basicUdiDi>B-10801902210538</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07911</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:05.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210521</udiDi>
    <basicUdiDi>B-10801902210521</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:04.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210514</udiDi>
    <basicUdiDi>B-10801902210514</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH-LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:00.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210507</udiDi>
    <basicUdiDi>B-10801902210507</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:14:00.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210453</udiDi>
    <basicUdiDi>B-10801902210453</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-07811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:59.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210446</udiDi>
    <basicUdiDi>B-10801902210446</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-07511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:58.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210439</udiDi>
    <basicUdiDi>B-10801902210439</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-07011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:54.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210422</udiDi>
    <basicUdiDi>B-10801902210422</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH-LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07711</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:53.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902210415</udiDi>
    <basicUdiDi>B-10801902210415</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire)</tradeName>
    <deviceName>CATH-LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:52.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902201130</udiDi>
    <basicUdiDi>B-10801902201130</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port</tradeName>
    <deviceName>CATH-LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07924</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:15.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902201123</udiDi>
    <basicUdiDi>B-10801902201123</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port</tradeName>
    <deviceName>CATH-LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07824</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:15.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902201116</udiDi>
    <basicUdiDi>B-10801902201116</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port</tradeName>
    <deviceName>CATH-LAB SHEATH INTRO SET</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-07724</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:14.349Z</lastUpdated>
  </row>
</eudamedExport>