<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902095916292</udiDi>
    <basicUdiDi>890209591629HK</basicUdiDi>
    <tradeName>Right Atrial ECG Adaptor With or Without Cable</tradeName>
    <deviceName>Right Atrial ECG Adaptor With or Without Cable</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91629</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:30.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095907108</udiDi>
    <basicUdiDi>890209595010GU</basicUdiDi>
    <tradeName>Huber Infusion Set without safety</tradeName>
    <deviceName>Huber Infusion set with/without safety</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010302</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90710</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:30.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095907016</udiDi>
    <basicUdiDi>890209595001GT</basicUdiDi>
    <tradeName>Huber Infusion Set with Safety</tradeName>
    <deviceName>Huber Infusion Set with safety</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010301</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90701</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:29.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903148</udiDi>
    <basicUdiDi>890209590314GG</basicUdiDi>
    <tradeName>Transfer Spikes</tradeName>
    <deviceName>Transfer Spike</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A99</emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90314</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:11.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095881408</udiDi>
    <basicUdiDi>890209588110HB</basicUdiDi>
    <tradeName>Blood Collection Needle &amp; Holder</tradeName>
    <deviceName>Blood Collection Needle &amp; Holder</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010502</emdnCode>
    <emdnDescription>NEEDLES FOR COLLECTION UNDER VACCUM, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88140</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:27.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095440094</udiDi>
    <basicUdiDi>890209544009FD</basicUdiDi>
    <tradeName>Securement Device Small/Medium/Large</tradeName>
    <deviceName>Securement Devices Small/Medium/Large</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03030199</emdnCode>
    <emdnDescription>ELASTIC FIXING BANDAGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44009</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:00.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095440063</udiDi>
    <basicUdiDi>890209544006F7</basicUdiDi>
    <tradeName>Neonatal Heat Loss Prevention Suit Small/Medium/Large</tradeName>
    <deviceName>Neonatal Heat Loss Prevention Suit Small/Medium/Large</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V028099</emdnCode>
    <emdnDescription>NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:22:59.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095201503</udiDi>
    <basicUdiDi>890209520150DV</basicUdiDi>
    <tradeName>Endotracheal Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01030201</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:52.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095146477</udiDi>
    <basicUdiDi>890209514450EV</basicUdiDi>
    <tradeName>Elastomeric Infusion pump</tradeName>
    <deviceName>Elastomeric Infusion Pump</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14647</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:33.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095135358</udiDi>
    <basicUdiDi>890209513535EX</basicUdiDi>
    <tradeName>Mini-midline Catheter (Peripheral Catheter)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010102</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETER SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13535</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:13.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095134948</udiDi>
    <basicUdiDi>890209513068EM</basicUdiDi>
    <tradeName>Polyspike</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A99</emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13494</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:13.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095134405</udiDi>
    <basicUdiDi>890209513440EK</basicUdiDi>
    <tradeName>Over The Needle (OTN) Catheter</tradeName>
    <deviceName>Over The Needle (OTN) Catheter</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010102</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETER SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13440</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:08.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095134269</udiDi>
    <basicUdiDi>890209513426ER</basicUdiDi>
    <tradeName>Arterial Cannula (without safety)</tradeName>
    <deviceName>Arterial Cannula with/without Safety Features</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010399</emdnCode>
    <emdnDescription>ARTERIAL CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13426</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:51.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095134177</udiDi>
    <basicUdiDi>890209513424EM</basicUdiDi>
    <tradeName>Arterial Cannula (Safety)</tradeName>
    <deviceName>Arterial Cannula with/without Safety Features</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010399</emdnCode>
    <emdnDescription>ARTERIAL CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13417</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:50.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095133538</udiDi>
    <basicUdiDi>890209513353EP</basicUdiDi>
    <tradeName>Luer Lock</tradeName>
    <deviceName>Luer Lock</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A070501</emdnCode>
    <emdnDescription>CAPS OR OBTURATORS, NON-PERFORABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13353</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:45.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095130803</udiDi>
    <basicUdiDi>890209513080EB</basicUdiDi>
    <tradeName>Stylet (Obturators)</tradeName>
    <deviceName>Stylet (Obturators)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A070599</emdnCode>
    <emdnDescription>CAPS OR OBTURATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13080</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:31.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095130674</udiDi>
    <basicUdiDi>890209513354ER</basicUdiDi>
    <tradeName>luer Caps</tradeName>
    <deviceName>Luer Caps</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A07050201</emdnCode>
    <emdnDescription>CAPS OR OBTURATORS, PERFORABLE WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>13067</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:25.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095110003</udiDi>
    <basicUdiDi>890209511050DL</basicUdiDi>
    <tradeName>Safety IV Cannula without injection port</tradeName>
    <deviceName>IV Cannula/ Catheter with/ without Safety Features</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0101010202</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, W/O INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:14.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095101001</udiDi>
    <basicUdiDi>890209510100D3</basicUdiDi>
    <tradeName>IV Cannula/ Catheter without port</tradeName>
    <deviceName>IV Cannula/ Catheter with/ without Safety Features</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0101010102</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, W/O INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:13.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095100011</udiDi>
    <basicUdiDi>890209510001CY</basicUdiDi>
    <tradeName>IV Cannula/ Catheter with port</tradeName>
    <deviceName>IV Cannula with/without Safety Features</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10001</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:18:12.227Z</lastUpdated>
  </row>
</eudamedExport>