<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902095404805</udiDi>
    <basicUdiDi>890209540480FB</basicUdiDi>
    <tradeName>Stomach Tubes</tradeName>
    <deviceName>Stomach Tubes</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020101</emdnCode>
    <emdnDescription>GASTRIC LAVAGE TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40480</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:35.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095403501</udiDi>
    <basicUdiDi>890209540351EX</basicUdiDi>
    <tradeName>Mucus Extractor with/without bacterial Filter</tradeName>
    <deviceName>Mucus Extractor with/without bacterial Filter</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40350</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:34.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095403013</udiDi>
    <basicUdiDi>890209540302EJ</basicUdiDi>
    <tradeName>Nasogastric Feeding tubes with/without guidewires (Single &amp; Dual port)/Levin's Tube</tradeName>
    <deviceName>Nasogastric Feeding tubes with/without guidewires (Single &amp; Dual port)/Levin's Tube</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020299</emdnCode>
    <emdnDescription>GASTROINTESTINAL FEEDING/ASPIRATION TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40301</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:29.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095400012</udiDi>
    <basicUdiDi>890209540002E3</basicUdiDi>
    <tradeName>Ryle’s Tube</tradeName>
    <deviceName>Ryle’s Tubes</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:28.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095303009</udiDi>
    <basicUdiDi>890209530300E3</basicUdiDi>
    <tradeName>Trans Urethral Resection Set (TUR Set)</tradeName>
    <deviceName>Trans Urethral Resection Set (TUR Set)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12019007</emdnCode>
    <emdnDescription>IRRIGATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:26.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095301609</udiDi>
    <basicUdiDi>890209530303E9</basicUdiDi>
    <tradeName>Foley Balloon Catheter</tradeName>
    <deviceName>Foley Balloon Catheter</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020202</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30160</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:22.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095301012</udiDi>
    <basicUdiDi>890209530102DV</basicUdiDi>
    <tradeName>Urine Collection Bags with/without volume meter</tradeName>
    <deviceName>Urine Collection Bags with/without volume meter</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>30101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:22.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095300602</udiDi>
    <basicUdiDi>890209530060E6</basicUdiDi>
    <tradeName>Female catheters</tradeName>
    <deviceName>Female catheters</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020199</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITHOUT BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:21.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095300404</udiDi>
    <basicUdiDi>890209530040DY</basicUdiDi>
    <tradeName>Rectal Catheter</tradeName>
    <deviceName>Rectal Catheter</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:20.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095300206</udiDi>
    <basicUdiDi>890209530521EM</basicUdiDi>
    <tradeName>Irrigation Set</tradeName>
    <deviceName>Irrigation Set</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:16.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095300107</udiDi>
    <basicUdiDi>890209530010DP</basicUdiDi>
    <tradeName>Nelaton catheters</tradeName>
    <deviceName>Nelaton catheters</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:15.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095204382</udiDi>
    <basicUdiDi>890209520151DX</basicUdiDi>
    <tradeName>Endotracheal Tubes (Plain / Cuff / Reinforced)</tradeName>
    <deviceName>Endotracheal Tubes (Plain / Cuff / Reinforced)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01030202</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20438</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:14.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095204245</udiDi>
    <basicUdiDi>890209520424EB</basicUdiDi>
    <tradeName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</tradeName>
    <deviceName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20424</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:09.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095204184</udiDi>
    <basicUdiDi>890209520415EA</basicUdiDi>
    <tradeName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</tradeName>
    <deviceName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20418</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:08.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095204153</udiDi>
    <basicUdiDi>890209520416EC</basicUdiDi>
    <tradeName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</tradeName>
    <deviceName>Breathing Circuit &amp; Accessories (Bain Circuit, Ventilator Circuit, HME Filter)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20415</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:07.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095201206</udiDi>
    <basicUdiDi>890209520120DL</basicUdiDi>
    <tradeName>Venturi Mask</tradeName>
    <deviceName>Venturi Mask</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:51.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095201152</udiDi>
    <basicUdiDi>890209520115DT</basicUdiDi>
    <tradeName>Oxygen Mask</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20115</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:47.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095201114</udiDi>
    <basicUdiDi>890209520111DK</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:46.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095200605</udiDi>
    <basicUdiDi>890209520060DT</basicUdiDi>
    <tradeName>Oxygen Catheters</tradeName>
    <deviceName>Oxygen Catheters</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:45.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095200506</udiDi>
    <basicUdiDi>890209520050DQ</basicUdiDi>
    <tradeName>Guedel Airways</tradeName>
    <deviceName>Guedel Airways</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010102</emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:45.184Z</lastUpdated>
  </row>
</eudamedExport>