<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08907265010060</udiDi>
    <basicUdiDi>8907265F003ZA</basicUdiDi>
    <tradeName>FEEDING BAG</tradeName>
    <deviceName>Feeding Bag (Enteral Feeding Bag)</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</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>GS-4028 KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:29.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265010022</udiDi>
    <basicUdiDi>8907265C001YH</basicUdiDi>
    <tradeName>VENEPORT</tradeName>
    <deviceName>INTRAVENOUS CANNULA</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</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-3210 KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:25.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265002454</udiDi>
    <basicUdiDi>8907265G001ZD</basicUdiDi>
    <tradeName>CLOSED WOUND DRAINAGE SYSTEM</tradeName>
    <deviceName>CLOSED WOUND DRAINAGE SYSTEM</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</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>GS-5002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:24.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265002201</udiDi>
    <basicUdiDi>8907265G007ZR</basicUdiDi>
    <tradeName>VACCU LINE (CROWN TIP)</tradeName>
    <deviceName>SURGICAL SUCTION / DRAINAGE DEVICES</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5129C KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:23.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265002003</udiDi>
    <basicUdiDi>8907265B007YN</basicUdiDi>
    <tradeName>ROMO SOFT</tradeName>
    <deviceName>TRACHEOSTOMY TUBE</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:22.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265000450</udiDi>
    <basicUdiDi>8907265A010Y4</basicUdiDi>
    <tradeName>URETHRAL CATHETER</tradeName>
    <deviceName>Foley Balloon Catheter (Latex)</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010101</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, CONICAL-OLIVARY TIP (URETHRAL CALIBRATION)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1012R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:18.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265000290</udiDi>
    <basicUdiDi>8907265A002Y5</basicUdiDi>
    <tradeName>NELATON CATHETER</tradeName>
    <deviceName>NELATON CATHETER</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</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-1004F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:17.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265000108</udiDi>
    <basicUdiDi>8907265G003ZH</basicUdiDi>
    <tradeName>FLEXO CATH</tradeName>
    <deviceName>THORACIC DRAINAGE CATHETER (CHEST DRAINAGE CATHETER)</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</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>GS-5034</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:17.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265000092</udiDi>
    <basicUdiDi>8907265B008YQ</basicUdiDi>
    <tradeName>GELATO</tradeName>
    <deviceName>SUCTION CATHETER</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</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-2025 P</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:16.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265000023</udiDi>
    <basicUdiDi>8907265C011YL</basicUdiDi>
    <tradeName>PM-O-LINE</tradeName>
    <deviceName>EXTENSION LINES</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03020102</emdnCode>
    <emdnDescription>HIGH PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3036 R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:12.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265000009</udiDi>
    <basicUdiDi>8907265B001YA</basicUdiDi>
    <tradeName>TRACHEOBRONCHIAL SUCTION CATHETER KIT – RIGHT</tradeName>
    <deviceName>ENDOTRACHEAL TUBE</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01040102</emdnCode>
    <emdnDescription>ENDOBRONCHIAL OROPHARYNGEAL TUBES, RIGHT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2111R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:11.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265209303</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT-SWT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2093</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265209402</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT-DWT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265209600</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT-DWT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265209808</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT-CM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2098</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265230406</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT- TIP UP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265230505</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT- HME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2305</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265230604</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT- TIP UP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2306</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265230703</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT- TIP UP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2307</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265230802</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT- TIP UP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2308</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:33:00.016Z</lastUpdated>
  </row>
</eudamedExport>