<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10801902200812</udiDi>
    <basicUdiDi>B-10801902200812</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-07690</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:43.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200805</udiDi>
    <basicUdiDi>B-10801902200805</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-07065</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:43.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200836</udiDi>
    <basicUdiDi>B-10801902200836</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07745</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:42.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200829</udiDi>
    <basicUdiDi>B-10801902200829</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07735</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:41.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200799</udiDi>
    <basicUdiDi>B-10801902200799</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-07035</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:24.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200782</udiDi>
    <basicUdiDi>B-10801902200782</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07980</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:23.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200775</udiDi>
    <basicUdiDi>B-10801902200775</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07965</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:23.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200768</udiDi>
    <basicUdiDi>B-10801902200768</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07835</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:22.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200751</udiDi>
    <basicUdiDi>B-10801902200751</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07800</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:18.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200744</udiDi>
    <basicUdiDi>B-10801902200744</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07590</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:17.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200737</udiDi>
    <basicUdiDi>B-10801902200737</basicUdiDi>
    <tradeName>Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band</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-07565</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:16.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200720</udiDi>
    <basicUdiDi>B-10801902200720</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-07665</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:15.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902200713</udiDi>
    <basicUdiDi>B-10801902200713</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-07645</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:12:11.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002116177</udiDi>
    <basicUdiDi>0827002CINC050-031_C1Y7</basicUdiDi>
    <tradeName>Flexor® Check-Flo®</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCFW-7.0-38-90-RB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:47:21.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002299856</udiDi>
    <basicUdiDi>0827002CINC050-031_C2Y9</basicUdiDi>
    <tradeName>Flexor® Check-Flo®</tradeName>
    <deviceName></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-7.0-18/38-45-RB-ANL1-HC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:46:37.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002562301</udiDi>
    <basicUdiDi>0827002CINC050-031_C2Y9</basicUdiDi>
    <tradeName>Flexor® Check-Flo®</tradeName>
    <deviceName></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-5.0-35-55-RB-HFANL0-HC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:46:21.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931896113137</udiDi>
    <basicUdiDi>69318961INS152SE</basicUdiDi>
    <tradeName>Sereny™ Hemostasis Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152A0615MS18D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:29:06.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931896129794</udiDi>
    <basicUdiDi>69318961INS152SE</basicUdiDi>
    <tradeName>Sereny™ Hemostasis Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152A0415MS18D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:29:06.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931896166287</udiDi>
    <basicUdiDi>69318961INS152SE</basicUdiDi>
    <tradeName>Sereny™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152A0407PS21T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:29:05.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931896166294</udiDi>
    <basicUdiDi>69318961INS152SE</basicUdiDi>
    <tradeName>Sereny™ Hemostasis Introducer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152A0407PA21T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:29:05.975Z</lastUpdated>
  </row>
</eudamedExport>