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<eudamedExport entity="devices">
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    <udiDi>08902120240125</udiDi>
    <basicUdiDi>8902120B014RQ</basicUdiDi>
    <tradeName>FLEXI COMFORT</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>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240316</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240323</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240330</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240347</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240354</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120240361</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO COMFORT</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>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2403S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120260000</udiDi>
    <basicUdiDi>8902120A007RL</basicUdiDi>
    <tradeName>Mid-Stream Urine Collection Set with Stopper</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0499</emdnCode>
    <emdnDescription>CLINICAL USE CONTAINERS (NON-IVD) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302229</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>Intra Cath-2</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302236</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>Intra Cath-2</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302243</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>Intra Cath-2</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302250</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>Intra Cath-2</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302267</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>Intra Cath-2</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302298</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>Intra Cath-2</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302311</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>KENZOCATH 14G</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302328</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>KENZOCATH 16G</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302335</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>KENZOCATH 18G</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302342</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>KENZOCATH 20G</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:59.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302359</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>KENZOCATH 22G</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:58.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302366</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>KENZOCATH 24G</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>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:58.961Z</lastUpdated>
  </row>
</eudamedExport>