<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10801902205596</udiDi>
    <basicUdiDi>B-10801902205596</basicUdiDi>
    <tradeName>EZ-IO 15mm Needle + Stabilizer Kit</tradeName>
    <deviceName>EZ-IO 15MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9018P-NO-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:47.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205626</udiDi>
    <basicUdiDi>B-10801902205626</basicUdiDi>
    <tradeName>EZ-IO 45mm Needle Set</tradeName>
    <deviceName>EZ-IO 45MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9079P-ME-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:46.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205619</udiDi>
    <basicUdiDi>B-10801902205619</basicUdiDi>
    <tradeName>EZ-IO 45mm Needle Set</tradeName>
    <deviceName>EZ-IO 45MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9079P-EE-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:45.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205589</udiDi>
    <basicUdiDi>B-10801902205589</basicUdiDi>
    <tradeName>EZ-IO 15mm Needle + Stabilizer Kit</tradeName>
    <deviceName>EZ-IO 15MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9018P-ME-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:28.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205572</udiDi>
    <basicUdiDi>B-10801902205572</basicUdiDi>
    <tradeName>EZ-IO 15mm Needle + Stabilizer Kit</tradeName>
    <deviceName>EZ-IO 15MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9018P-EE-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:28.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205565</udiDi>
    <basicUdiDi>B-10801902205565</basicUdiDi>
    <tradeName>EZ-IO 15mm Needle Set</tradeName>
    <deviceName>EZ IO 15MM NEEDLE SET/EU CONFIGURAT</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9018-EU-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:27.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205558</udiDi>
    <basicUdiDi>B-10801902205558</basicUdiDi>
    <tradeName>EZ-IO 25mm Needle + Stabilizer Kit</tradeName>
    <deviceName>EZ-IO 25MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001P-NO-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:26.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205541</udiDi>
    <basicUdiDi>B-10801902205541</basicUdiDi>
    <tradeName>EZ-IO 25mm Needle + Stabilizer Kit</tradeName>
    <deviceName>EZ-IO 25MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001P-ME-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:22.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205534</udiDi>
    <basicUdiDi>B-10801902205534</basicUdiDi>
    <tradeName>EZ-IO 25mm Needle + Stabilizer Kit</tradeName>
    <deviceName>EZ-IO 25MM NEEDLE + STABILIZER BX/5</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001P-EE-005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:21.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902205527</udiDi>
    <basicUdiDi>B-10801902205527</basicUdiDi>
    <tradeName>EZ-IO 25mm Needle Set</tradeName>
    <deviceName>EZ IO 25MM NEEDLE SET/EU CONFIGURAT</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-EU-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:20.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>10801902202298</udiDi>
    <basicUdiDi>B-10801902202298</basicUdiDi>
    <tradeName>Manual Needle Set</tradeName>
    <deviceName>EZ-IO MANUAL NEEDLE SET (BOX OF 6)</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9094</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:13:19.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704204298</udiDi>
    <basicUdiDi>B-04026704204298</basicUdiDi>
    <tradeName>PercuQuick One-Step Dilator Set for percutaneous dilation tracheostomy</tradeName>
    <deviceName>PERCUQUICK ONE-STEP SET, PDT</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121560-000090</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:58:17.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704204281</udiDi>
    <basicUdiDi>B-04026704204281</basicUdiDi>
    <tradeName>PercuQuick One-Step Dilator Set for percutaneous dilation tracheostomy</tradeName>
    <deviceName>PERCUQUICK ONE-STEP SET, PDT</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121560-000080</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:58:13.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704106295</udiDi>
    <basicUdiDi>B-04026704106295</basicUdiDi>
    <tradeName>Rusch PercuQuick PVC for use with PDT only, first step Dilator for PDT</tradeName>
    <deviceName>FIRST STEP DILATOR FOR PDT</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121503-000000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:56:47.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704105908</udiDi>
    <basicUdiDi>B-04026704105908</basicUdiDi>
    <tradeName>Rusch Tracheofix PVC Tracheostomy tube set PDT</tradeName>
    <deviceName>TRACHEOFIX TRACHEOSTOMY TUBE SET PD</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121501-000100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:56:46.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704105892</udiDi>
    <basicUdiDi>B-04026704105892</basicUdiDi>
    <tradeName>Rusch Tracheofix PVC Tracheostomy tube set PDT</tradeName>
    <deviceName>TRACHEOFIX TRACHEOSTOMY TUBE SET PD</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121501-000085</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:56:45.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704105885</udiDi>
    <basicUdiDi>B-04026704105885</basicUdiDi>
    <tradeName>Rusch Tracheofix PVC Tracheostomy tube set PDT</tradeName>
    <deviceName>TRACHEOFIX TRACHEOSTOMY TUBE SET PD</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121501-000070</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:56:44.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704104789</udiDi>
    <basicUdiDi>B-04026704104789</basicUdiDi>
    <tradeName>PercuTwist Set, solo</tradeName>
    <deviceName>PDT SET</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121557-000090</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:56:39.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704104772</udiDi>
    <basicUdiDi>B-04026704104772</basicUdiDi>
    <tradeName>PercuTwist Set, solo</tradeName>
    <deviceName>PDT SET</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121557-000080</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:56:38.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704104765</udiDi>
    <basicUdiDi>B-04026704104765</basicUdiDi>
    <tradeName>PercuTwist Set, solo</tradeName>
    <deviceName>PDT SET</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010699</emdnCode>
    <emdnDescription>PERCUTANEOUS TRACHEOSTOMY KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121557-000070</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:56:37.748Z</lastUpdated>
  </row>
</eudamedExport>