<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902120331427</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>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-3314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:46.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120332615</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>INFLOW SET 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-3326N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:46.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120332622</udiDi>
    <basicUdiDi>8902120C014RX</basicUdiDi>
    <tradeName>INFLOW 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-3326</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:53:46.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250273753790</udiDi>
    <basicUdiDi>42502737NIV50011s0000005W</basicUdiDi>
    <tradeName>SL OP IP  Light-protected, PUR material</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fresenius Kabi AG</manufacturerName>
    <manufacturerSrn>DE-MF-000009273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M77460068Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:05:40.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289430261</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N403</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289430926</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N110</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289430933</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N112</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289430940</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N410</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289430988</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N113</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289430995</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N510</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289431138</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N111</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289431145</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N111(60D)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809289431152</udiDi>
    <basicUdiDi>880928943EZ4U</basicUdiDi>
    <tradeName>EZ REGULAR N112(60D)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEINNTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000027366</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MTEZ-UM-E00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:53:41.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>05607716007009</udiDi>
    <basicUdiDi>56077161007U</basicUdiDi>
    <tradeName>05607716007009</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Produtos Médicos Hospitalares, SA</manufacturerName>
    <manufacturerSrn>PT-MF-000007631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102.0700</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:04:02.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>05607716007276</udiDi>
    <basicUdiDi>56077161007U</basicUdiDi>
    <tradeName>05607716007276</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Produtos Médicos Hospitalares, SA</manufacturerName>
    <manufacturerSrn>PT-MF-000007631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110.0727</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:04:02.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>05607716007399</udiDi>
    <basicUdiDi>56077161007U</basicUdiDi>
    <tradeName>05607716007399</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Produtos Médicos Hospitalares, SA</manufacturerName>
    <manufacturerSrn>PT-MF-000007631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108.0739</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:04:02.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>05607716007450</udiDi>
    <basicUdiDi>56077161007U</basicUdiDi>
    <tradeName>05607716007450</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Produtos Médicos Hospitalares, SA</manufacturerName>
    <manufacturerSrn>PT-MF-000007631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109.0745</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:04:02.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>05607716007467</udiDi>
    <basicUdiDi>56077161007U</basicUdiDi>
    <tradeName>05607716007467</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Produtos Médicos Hospitalares, SA</manufacturerName>
    <manufacturerSrn>PT-MF-000007631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109.0746</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:04:02.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>05607716007481</udiDi>
    <basicUdiDi>56077161007U</basicUdiDi>
    <tradeName>05607716007481</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Produtos Médicos Hospitalares, SA</manufacturerName>
    <manufacturerSrn>PT-MF-000007631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106.0748</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:04:02.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>05607716007498</udiDi>
    <basicUdiDi>56077161007U</basicUdiDi>
    <tradeName>05607716007498</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Produtos Médicos Hospitalares, SA</manufacturerName>
    <manufacturerSrn>PT-MF-000007631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103.0749</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T18:04:02.149Z</lastUpdated>
  </row>
</eudamedExport>