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<eudamedExport entity="devices">
  <row>
    <udiDi>08907265608403</udiDi>
    <basicUdiDi>8907265M0022U</basicUdiDi>
    <tradeName>ROMO JET</tradeName>
    <deviceName>HYPODERMIC SYRINGE</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>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-6084</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:12.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265602807</udiDi>
    <basicUdiDi>8907265G017ZU</basicUdiDi>
    <tradeName>Dermark</tradeName>
    <deviceName>Surgical Skin Marker</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>V9004</emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-6028</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:10.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265508406</udiDi>
    <basicUdiDi>8907265I001ZT</basicUdiDi>
    <tradeName>Klik Clamp</tradeName>
    <deviceName>Umbilical Cord Clamp</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>V0202</emdnCode>
    <emdnDescription>UMBILICAL CLAMPS AND CLIPPERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS 5084</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:10.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265501803</udiDi>
    <basicUdiDi>8907265B009YS</basicUdiDi>
    <tradeName>MUCUS EXTRACTOR WITHOUT FILTER</tradeName>
    <deviceName>MUCUS EXTRACTOR</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>R05010302</emdnCode>
    <emdnDescription>DOUBLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5018</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:08.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265400809</udiDi>
    <basicUdiDi>8907265F001Z6</basicUdiDi>
    <tradeName>INFANT FEEDING TUBE</tradeName>
    <deviceName>NASOGASTRIC 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>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-4008</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:06.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265304015</udiDi>
    <basicUdiDi>8907265C005YR</basicUdiDi>
    <tradeName>BI-VALVE</tradeName>
    <deviceName>3-WAY STOP COCK</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>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3040LR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:04.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265300406</udiDi>
    <basicUdiDi>8907265C002YK</basicUdiDi>
    <tradeName>SCALP VEIN SET</tradeName>
    <deviceName>SCALP VEIN SET</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>A01010202</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3004</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:03.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265304503</udiDi>
    <basicUdiDi>8907265H001ZL</basicUdiDi>
    <tradeName>INTRA SHIELD</tradeName>
    <deviceName>I.V. Cannula Fixator (Dressing &amp; Securement 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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04010201</emdnCode>
    <emdnDescription>NON-WOVEN FIXING DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3045</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:02.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265208801</udiDi>
    <basicUdiDi>8907265B025YQ</basicUdiDi>
    <tradeName>ROMO VENTE</tradeName>
    <deviceName>BAIN CIRCUIT</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-2088</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:48.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265201208</udiDi>
    <basicUdiDi>8907265B006YL</basicUdiDi>
    <tradeName>GUEDEL AIRWAYS</tradeName>
    <deviceName>GUEDEL AIRWAYS (Oropharyngeal Airways)</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>R010102</emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:44.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265107807</udiDi>
    <basicUdiDi>8907265A015YE</basicUdiDi>
    <tradeName>SILKO-CATH (2-WAY)</tradeName>
    <deviceName>Foley Balloon Catheter (Silicone)</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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1078</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:43.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265101003</udiDi>
    <basicUdiDi>8907265A001Y3</basicUdiDi>
    <tradeName>MALE CATH</tradeName>
    <deviceName>Male External 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 I</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>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:42.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265100808</udiDi>
    <basicUdiDi>8907265A003Y7</basicUdiDi>
    <tradeName>T.U.R. Set</tradeName>
    <deviceName>TRANS URETHRAL RESECTION IRRIGATION SET</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>U0180</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1008</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:41.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265030006</udiDi>
    <basicUdiDi>8907265N0012Z</basicUdiDi>
    <tradeName>HYPODERMIC NEEDLE</tradeName>
    <deviceName>HYPODERMIC NEEDLE</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>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-6088</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:37.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265011678</udiDi>
    <basicUdiDi>8907265D001YQ</basicUdiDi>
    <tradeName>RMS</tradeName>
    <deviceName>BLOOD ADMINISTRATION SET (TRANSFUSION SET)</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>B010201</emdnCode>
    <emdnDescription>WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-3052 KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:37.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265011425</udiDi>
    <basicUdiDi>8907265B012YF</basicUdiDi>
    <tradeName>VENTILATOR CIRCUIT</tradeName>
    <deviceName>VENTILATOR CIRCUIT</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-2092 KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:36.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265011142</udiDi>
    <basicUdiDi>8907265B019YV</basicUdiDi>
    <tradeName>AERO MIST</tradeName>
    <deviceName>NEBULIZER: Mask / Mouth Piece with Nebulization Chamber and Tubing.</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2074S KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:35.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265011067</udiDi>
    <basicUdiDi>8907265B014YK</basicUdiDi>
    <tradeName>FLEXI MASK</tradeName>
    <deviceName>OXYGEN DELIVERY 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2020S KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:31.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265011005</udiDi>
    <basicUdiDi>8907265C014YS</basicUdiDi>
    <tradeName>RMS VENTED INFUSION SET</tradeName>
    <deviceName>INFUSION SET</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS 3060 KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:30.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265010190</udiDi>
    <basicUdiDi>8907265G005ZM</basicUdiDi>
    <tradeName>ROMO-SEAL</tradeName>
    <deviceName>UNDER WATER SEAL 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-5020 KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:29.959Z</lastUpdated>
  </row>
</eudamedExport>