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<eudamedExport entity="devices">
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    <udiDi>08902095950579</udiDi>
    <basicUdiDi>890209590030FX</basicUdiDi>
    <tradeName>AV Fistula Needle with/without safety features</tradeName>
    <deviceName>AV Fistula Needle with/without safety features</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95057</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:36.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095918296</udiDi>
    <basicUdiDi>890209591801H7</basicUdiDi>
    <tradeName>Back-check valves with/without caps</tradeName>
    <deviceName>Back-check valves with/without caps</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>A0799</emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91829</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:35.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095906569</udiDi>
    <basicUdiDi>890209590656HF</basicUdiDi>
    <tradeName>IV Fixator</tradeName>
    <deviceName>IV Fixator</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>M04010202</emdnCode>
    <emdnDescription>POLYURETHANE FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90656</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:28.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095904510</udiDi>
    <basicUdiDi>890209590450GR</basicUdiDi>
    <tradeName>Suction Control Valve with / without Extension Tube</tradeName>
    <deviceName>Suction Control Valve with / without Extension 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>R05010102</emdnCode>
    <emdnDescription>RESPIRATORY SUCTION PROBES WITH CONTROL HOLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90451</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:22.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903605</udiDi>
    <basicUdiDi>890209590360GP</basicUdiDi>
    <tradeName>Peritoneal Dialysis Transfusion Set</tradeName>
    <deviceName>Peritoneal Dialysis Transfusion Set</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>F02020201</emdnCode>
    <emdnDescription>TEMPORARY PERITONAEAL DIALYSIS LINES, GRAVITY (APD)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90360</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:16.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903506</udiDi>
    <basicUdiDi>890209590350GL</basicUdiDi>
    <tradeName>Peritoneal Dialysis Catheter Kit</tradeName>
    <deviceName>Peritoneal Dialysis Catheter Kit</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>F900101</emdnCode>
    <emdnDescription>PERITONEAL DIALYSIS CATHETERS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90350</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:15.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095902264</udiDi>
    <basicUdiDi>890209590286H4</basicUdiDi>
    <tradeName>Sterile Bottle caps</tradeName>
    <deviceName>Sterile Bottle caps</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>A0799</emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90226</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:05.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095902202</udiDi>
    <basicUdiDi>890209590220G6</basicUdiDi>
    <tradeName>Umbilical Cord Clamp</tradeName>
    <deviceName>Umbilical Cord Clamp</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>V0202</emdnCode>
    <emdnDescription>UMBILICAL CLAMPS AND CLIPPERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:04.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095901205</udiDi>
    <basicUdiDi>890209590120FZ</basicUdiDi>
    <tradeName>Under Water Sealed Drainage System</tradeName>
    <deviceName>Under Water Sealed Drainage System</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>A060203</emdnCode>
    <emdnDescription>PLEURAL DRAINAGES WITH VALVE AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:47.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095901106</udiDi>
    <basicUdiDi>890209590110FW</basicUdiDi>
    <tradeName>Abdominal Drainage Set</tradeName>
    <deviceName>Abdominal Drainage 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>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:46.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095900802</udiDi>
    <basicUdiDi>890209590081GG</basicUdiDi>
    <tradeName>Thoracic Drainage Catheters with/without Trocar</tradeName>
    <deviceName>Thoracic Drainage Catheters with/without Trocar</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>A0601010401</emdnCode>
    <emdnDescription>THORACIC DRAINAGES (STRAIGHT AND ANGLED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:42.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095900604</udiDi>
    <basicUdiDi>890209590060G8</basicUdiDi>
    <tradeName>Redon Drainage Tubes</tradeName>
    <deviceName>Redon Drainage 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>A0601010101</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH REDON TYPE RIGID CONTAINER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:41.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095900437</udiDi>
    <basicUdiDi>890209590051G7</basicUdiDi>
    <tradeName>Closed Wound Suction Unit</tradeName>
    <deviceName>Closed Wound Suction Unit</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>A0601010103</emdnCode>
    <emdnDescription>BELLOWS DRAINAGE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90043</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:40.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095882900</udiDi>
    <basicUdiDi>890209588292JC</basicUdiDi>
    <tradeName>Blood Collection Set (without Safety)</tradeName>
    <deviceName>Blood Collection Set with/ without Safety features</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>A01018099</emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88290</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:34.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095882801</udiDi>
    <basicUdiDi>890209588291JA</basicUdiDi>
    <tradeName>Blood Collection Set (with Safety)</tradeName>
    <deviceName>Blood Collection Set with/ without Safety features</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>A01018099</emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88280</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:33.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095701553</udiDi>
    <basicUdiDi>890209570155FW</basicUdiDi>
    <tradeName>Blood Line Set</tradeName>
    <deviceName>Blood Line 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>F020180</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70155</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:21.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095701508</udiDi>
    <basicUdiDi>890209570150FL</basicUdiDi>
    <tradeName>Transfusion Pump Set</tradeName>
    <deviceName>Transfusion Pump 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>Z121799</emdnCode>
    <emdnDescription>BLOOD TRANSFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70150</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:19.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095700914</udiDi>
    <basicUdiDi>890209570091FV</basicUdiDi>
    <tradeName>Transfusion Sets (BT Set)</tradeName>
    <deviceName>Transfusion Sets (BT 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>A03010102</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70091</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:15.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095406038</udiDi>
    <basicUdiDi>890209590141G9</basicUdiDi>
    <tradeName>Yankaur Suction Set (Suction tube and/or Handle)</tradeName>
    <deviceName>Yankaur Suction Set (Suction tube and/or Handle)</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>A0601010499</emdnCode>
    <emdnDescription>DRAINAGE PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40603</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:22:53.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095161708</udiDi>
    <basicUdiDi>890209540600EV</basicUdiDi>
    <tradeName>Feeding Bags</tradeName>
    <deviceName>Feeding Bags</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>A080101</emdnCode>
    <emdnDescription>ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16170</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:22:53.108Z</lastUpdated>
  </row>
</eudamedExport>