<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902120100481</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 20FG</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>2026-06-23T20:54:17.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120100498</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>NEL-CATH 22FG</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>2026-06-23T20:54:17.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101020</udiDi>
    <basicUdiDi>8902120A001R8</basicUdiDi>
    <tradeName>MALE CATH</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>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:02.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101037</udiDi>
    <basicUdiDi>8902120A001R8</basicUdiDi>
    <tradeName>MALE CATH</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>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:02.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101044</udiDi>
    <basicUdiDi>8902120A001R8</basicUdiDi>
    <tradeName>MALE CATH</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>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:02.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101051</udiDi>
    <basicUdiDi>8902120A001R8</basicUdiDi>
    <tradeName>MALE CATH</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>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:02.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101822</udiDi>
    <basicUdiDi>8902120A009RQ</basicUdiDi>
    <tradeName>UROMETER 250 ML</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1018-250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:02.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101839</udiDi>
    <basicUdiDi>8902120A009RQ</basicUdiDi>
    <tradeName>UROMETER 500 ML</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1018-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101846</udiDi>
    <basicUdiDi>8902120A009RQ</basicUdiDi>
    <tradeName>UROMETER 500 ML</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1018-500E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101853</udiDi>
    <basicUdiDi>8902120A009RQ</basicUdiDi>
    <tradeName>SPARE BAG FOR UROMETER - 500 ML</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1018SB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120101860</udiDi>
    <basicUdiDi>8902120A009RQ</basicUdiDi>
    <tradeName>MEASUREXE</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1018M-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102027</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102034</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102041</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102058</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102065</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020 R5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102072</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102089</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020 R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102096</udiDi>
    <basicUdiDi>8902120A008RN</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030302</emdnCode>
    <emdnDescription>HOURLY DIURESIS MEASUREMENT SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020AH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120102201</udiDi>
    <basicUdiDi>8902120A012RD</basicUdiDi>
    <tradeName>URINE COLLECTION BAG</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>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1020B (NS)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.797Z</lastUpdated>
  </row>
</eudamedExport>