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<eudamedExport entity="devices">
  <row>
    <udiDi>08902095918005</udiDi>
    <basicUdiDi>890209591800H5</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-000043011</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>91800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:34.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903711</udiDi>
    <basicUdiDi>890209590371GU</basicUdiDi>
    <tradeName>Dialyzer (Dialysis Filter medium flux)</tradeName>
    <deviceName>Dialyzer (Dialysis Filter)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>90371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:22.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903698</udiDi>
    <basicUdiDi>890209590369H9</basicUdiDi>
    <tradeName>Dialyzer (Dialysis Filter high flux)</tradeName>
    <deviceName>Dialyzer (Dialysis Filter)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060303</emdnCode>
    <emdnDescription>DIALYSERS - UFC &gt; 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>90369</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:18.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903650</udiDi>
    <basicUdiDi>890209590365GZ</basicUdiDi>
    <tradeName>Dialyzer (Dialysis Filter low flux)</tradeName>
    <deviceName>Dialyzer (Dialysis Filter)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060103</emdnCode>
    <emdnDescription>DIALYSERS - UFC &lt; 18 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>90365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:17.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903117</udiDi>
    <basicUdiDi>890209590315GJ</basicUdiDi>
    <tradeName>Prefilled Syringe with 0.9% Saline Solution</tradeName>
    <deviceName>Prefilled Syringe with 0.9% Saline Solution</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010701</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90311</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:10.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095903100</udiDi>
    <basicUdiDi>890209590310G8</basicUdiDi>
    <tradeName>Disinfecting Port Protector (Polyswab 70%IPA+2% Chlohexidine)</tradeName>
    <deviceName>Disinfecting Port Protector</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0706</emdnCode>
    <emdnDescription>ANTISEPTIC CONNECTOR PROTECTORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>90310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:10.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095902882</udiDi>
    <basicUdiDi>890209590309GP</basicUdiDi>
    <tradeName>Disinfecting Port Protector (Polyswab 70%IPA)</tradeName>
    <deviceName>Disinfecting Port Protector - 70% IPA</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0706</emdnCode>
    <emdnDescription>ANTISEPTIC CONNECTOR PROTECTORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>90288</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:09.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095900307</udiDi>
    <basicUdiDi>890209590031FZ</basicUdiDi>
    <tradeName>AV Fistula Needle</tradeName>
    <deviceName>AV Fistula Needle</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</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>90030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:35.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095882504</udiDi>
    <basicUdiDi>890209588250HU</basicUdiDi>
    <tradeName>Luer Adaptors</tradeName>
    <deviceName>Luer Adaptors</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010199</emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88250</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:29.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095882009</udiDi>
    <basicUdiDi>890209588220HK</basicUdiDi>
    <tradeName>Blood Collection Holder with Safety</tradeName>
    <deviceName>Blood Collection Needle &amp; Holder</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010501</emdnCode>
    <emdnDescription>NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:28.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095881101</udiDi>
    <basicUdiDi>890209588120HE</basicUdiDi>
    <tradeName>Blood Collection Needle &amp; Holder</tradeName>
    <deviceName>Blood Collection Needle &amp; Holder</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</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>88110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:26.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095870105</udiDi>
    <basicUdiDi>890209591328H2</basicUdiDi>
    <tradeName>ABG Syringe</tradeName>
    <deviceName>ABG Syringe</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:22.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095510612</udiDi>
    <basicUdiDi>890209551064FB</basicUdiDi>
    <tradeName>Hypodermic Syringe with needle</tradeName>
    <deviceName>Hypodermic Syringe</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:13.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095504420</udiDi>
    <basicUdiDi>890209597099JL</basicUdiDi>
    <tradeName>Enteral Caps</tradeName>
    <deviceName>Enteral Caps</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</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>50442</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:13.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095504079</udiDi>
    <basicUdiDi>890209591945HY</basicUdiDi>
    <tradeName>Blunt Fill Needle</tradeName>
    <deviceName>Blunt Fill Needle</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019001</emdnCode>
    <emdnDescription>BLUNT NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50407</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:09.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095503829</udiDi>
    <basicUdiDi>890209550382FM</basicUdiDi>
    <tradeName>Closed System Drug Transfer Device (CSTD)</tradeName>
    <deviceName>Closed System Drug Transfer Device (CSTD)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50382</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:08.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095503751</udiDi>
    <basicUdiDi>890209550375FQ</basicUdiDi>
    <tradeName>Closed System Drug Transfer Device (CSTD)</tradeName>
    <deviceName>Closed System Drug Transfer Device (CSTD)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50375</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:06.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095503737</udiDi>
    <basicUdiDi>890209550373FL</basicUdiDi>
    <tradeName>Closed System Drug Transfer Device (CSTD)</tradeName>
    <deviceName>Closed System Drug Transfer Device (CSTD)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50373</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:05.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095503676</udiDi>
    <basicUdiDi>890209550367FR</basicUdiDi>
    <tradeName>Closed System Drug Transfer Device (CSTD)</tradeName>
    <deviceName>Closed System Drug Transfer Device (CSTD)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50367</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:01.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095503607</udiDi>
    <basicUdiDi>890209550360FB</basicUdiDi>
    <tradeName>Closed System Drug Transfer Device (CSTD)</tradeName>
    <deviceName>Closed System Drug Transfer Device (CSTD)</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043011</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50360</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:23:01.110Z</lastUpdated>
  </row>
</eudamedExport>