<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06935491700280</udiDi>
    <basicUdiDi>B-06935491700280</basicUdiDi>
    <tradeName>BBD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IV-03</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:00.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700228</udiDi>
    <basicUdiDi>B-06935491700228</basicUdiDi>
    <tradeName>BBD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IV-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:47:52.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>03615370006469</udiDi>
    <basicUdiDi>697262011BQIV1E8</basicUdiDi>
    <tradeName>03615370006469</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BQ Plus Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010259</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PER1Y</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T10:24:30.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306012</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>RMS VENTED INFUSION SET</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306104</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>INTRA FLOW AS</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3061AS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306128</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>INTRA FLOW AS WITH NEEDLE</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3061N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306203</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>RMS NON-VENTED INFUSION SET</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306302</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>TRANSFLOW WITH NEEDLE</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3063N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306319</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>TRANSFLOW</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3063</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306401</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>MICROPERF</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3064</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306807</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>BURETTA</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3068</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306814</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>BURETTA WITH NEEDLE</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3068N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120306821</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>BURETTA</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3068E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120307705</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>STERI FLO</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3077</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120307712</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>STERI FLO WITH NEEDLE</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3077N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120308214</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>VOLUFIX PLUS WITH NEEDLE</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3082PN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120308221</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>VOLUFIX PLUS</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3082P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120308252</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>VOLUFIX</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120308269</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>VOLUFIX WITH NEEDLE</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3082N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120309419</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>VOLUMETRIC SET</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>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-3094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:56.398Z</lastUpdated>
  </row>
</eudamedExport>