<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902120904508</udiDi>
    <basicUdiDi>8902120Q001UQ</basicUdiDi>
    <tradeName>ECG ELECTRODE</tradeName>
    <deviceName>Electrocardiograph Electrodes</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>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-9045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:42.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120902405</udiDi>
    <basicUdiDi>8902120G016SX</basicUdiDi>
    <tradeName>Trimmer</tradeName>
    <deviceName>Trimmer</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>L0399</emdnCode>
    <emdnDescription>GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GS-9024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:38.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120608307</udiDi>
    <basicUdiDi>8902120B022RP</basicUdiDi>
    <tradeName>BREAZER</tradeName>
    <deviceName>Respirometer</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>R900902</emdnCode>
    <emdnDescription>INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-6083</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:37.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120600219</udiDi>
    <basicUdiDi>8902120G011SM</basicUdiDi>
    <tradeName>BUBBLE TUBE SUCTION</tradeName>
    <deviceName>Suction Bubble 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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-6002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:36.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120511010</udiDi>
    <basicUdiDi>8902120F005SK</basicUdiDi>
    <tradeName>BILE BAG</tradeName>
    <deviceName>Bile 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>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:35.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120502001</udiDi>
    <basicUdiDi>8902120G005SS</basicUdiDi>
    <tradeName>ROMO-SEAL</tradeName>
    <deviceName>Under Water Seal Drainage System</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>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:31.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120501714</udiDi>
    <basicUdiDi>8902120G008SY</basicUdiDi>
    <tradeName>SUCTION CONNECTING TUBE</tradeName>
    <deviceName>Surgical Suction 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>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5017</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:30.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120501011</udiDi>
    <basicUdiDi>8902120G003SN</basicUdiDi>
    <tradeName>CHEST DRAINAGE CATHETER</tradeName>
    <deviceName>Thoracic Drainage 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>A0601010401</emdnCode>
    <emdnDescription>THORACIC DRAINAGES (STRAIGHT AND ANGLED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:30.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120500410</udiDi>
    <basicUdiDi>8902120G017SZ</basicUdiDi>
    <tradeName>REDON DRAIN WITHOUT NEEDLE</tradeName>
    <deviceName>Redon Drain Catheter with/without Needle</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>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:29.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120500106</udiDi>
    <basicUdiDi>8902120G001SJ</basicUdiDi>
    <tradeName>ROMO VAC SET</tradeName>
    <deviceName>Closed Wound Drainage System</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>A0601010103</emdnCode>
    <emdnDescription>BELLOWS DRAINAGE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5002N</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:25.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120402004</udiDi>
    <basicUdiDi>8902120F006SM</basicUdiDi>
    <tradeName>Colobag</tradeName>
    <deviceName>Closed System Colostomy 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>A1001010101</emdnCode>
    <emdnDescription>ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-4020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:24.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120400413</udiDi>
    <basicUdiDi>8902120F001SB</basicUdiDi>
    <tradeName>RYLE'S TUBE 6FG</tradeName>
    <deviceName>Nasogastric 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>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-4004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:23.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120305718</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>MEASURED VOLUME IV SET WITH NEEDLE</tradeName>
    <deviceName>Infusion Set with / without Needle</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3057</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:22.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120304001</udiDi>
    <basicUdiDi>8902120C005RW</basicUdiDi>
    <tradeName>BI-VALVE</tradeName>
    <deviceName>Three way stop cock</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>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:18.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120303219</udiDi>
    <basicUdiDi>8902120C011RR</basicUdiDi>
    <tradeName>VEIN-O-LINE 'L'</tradeName>
    <deviceName>Extension Line</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>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:18.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120302212</udiDi>
    <basicUdiDi>8902120C001RN</basicUdiDi>
    <tradeName>INTRA CATH-2</tradeName>
    <deviceName>INTRA VENOUS CANNULA</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>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:17.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120300805</udiDi>
    <basicUdiDi>8902120C019S9</basicUdiDi>
    <tradeName>Romsons CVP MANOMETER</tradeName>
    <deviceName>C.V.P MANOMETER</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>Z1203020301</emdnCode>
    <emdnDescription>INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:16.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120252005</udiDi>
    <basicUdiDi>8902120A007RL</basicUdiDi>
    <tradeName>Mid-Stream Urine Collection Set with Funnel</tradeName>
    <deviceName>MID-STREAM URINE COLLECTION SET</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-252</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:12.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120209511</udiDi>
    <basicUdiDi>8902120B013RN</basicUdiDi>
    <tradeName>HME FILTER</tradeName>
    <deviceName>Disposable Heat and Moisture Exchange Bacterial/Viral Filter</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>R040102</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-2095</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:11.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120207418</udiDi>
    <basicUdiDi>8902120B019S2</basicUdiDi>
    <tradeName>AERO-MIST</tradeName>
    <deviceName>NEBULISER: Mask / Mouth Piece with Nebulization Chamber and Tubing</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-2074</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:10.892Z</lastUpdated>
  </row>
</eudamedExport>