<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902120201614</udiDi>
    <basicUdiDi>8902120B014RQ</basicUdiDi>
    <tradeName>OXY SET</tradeName>
    <deviceName>OXYGEN DELIVERY DEVICES</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:10.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120201218</udiDi>
    <basicUdiDi>8902120B006RR</basicUdiDi>
    <tradeName>GUEDEL AIRWAYS</tradeName>
    <deviceName>Guedel Airways</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010102</emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:06.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120200808</udiDi>
    <basicUdiDi>8902120B007RT</basicUdiDi>
    <tradeName>TRACHEOSTOMY TUBE-PLAIN</tradeName>
    <deviceName>Tracheostomy Tube</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:05.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120200617</udiDi>
    <basicUdiDi>8902120B008RV</basicUdiDi>
    <tradeName>SUCTION CATHETER PLAIN</tradeName>
    <deviceName>SUCTION CATHETER</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2006</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:04.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120200211</udiDi>
    <basicUdiDi>8902120B001RF</basicUdiDi>
    <tradeName>ENDOTRACHEAL TUBE-PLAIN</tradeName>
    <deviceName>Endotracheal Tube</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01030101</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFLESS, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:03.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102416</udiDi>
    <basicUdiDi>8902120A013RF</basicUdiDi>
    <tradeName>LEG BAG</tradeName>
    <deviceName>Closed Ended Wearable Urine Collection Bag</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>Piyasada</deviceStatus>
    <reference>GS-1024A (NS)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:48.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102102</udiDi>
    <basicUdiDi>8902120A012RD</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</tradeName>
    <deviceName>Urine Collection Bag</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>Piyasada</deviceStatus>
    <reference>GS-1020A (NS)</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:47.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102010</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</tradeName>
    <deviceName>Urine Collection Bag</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:43.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101815</udiDi>
    <basicUdiDi>8902120A009RQ</basicUdiDi>
    <tradeName>UROMETER 100 ML</tradeName>
    <deviceName>Measured Volume Chamber with Urine Collection Bag</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1018-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:42.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101402</udiDi>
    <basicUdiDi>8902120G015SV</basicUdiDi>
    <tradeName>CATH CLAMP</tradeName>
    <deviceName>Catheter Clamp</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L031307</emdnCode>
    <emdnDescription>TOWEL AND TUBE CLAMPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:42.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101013</udiDi>
    <basicUdiDi>8902120A001R8</basicUdiDi>
    <tradeName>MALE CATH</tradeName>
    <deviceName>Male External Catheter</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:41.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100405</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 24FG</tradeName>
    <deviceName>Urethral Catheter</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:37.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902021508409</udiDi>
    <basicUdiDi>8902120I001SY</basicUdiDi>
    <tradeName>KLIK CLAMP</tradeName>
    <deviceName>Umbilical Cord Clamp</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-5084</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:22:48.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100412</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 6FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:17.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100429</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 8FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:17.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100436</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 10FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:17.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100443</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 12FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:17.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100450</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 14FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:17.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100467</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 16FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:17.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100474</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 18FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</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>GS-1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:17.316Z</lastUpdated>
  </row>
</eudamedExport>