<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00890404520095</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520095</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T23:00:01.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404520088</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520088</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:58:02.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404520071</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520071</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:56:21.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404520064</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520064</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:54:16.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404520057</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520057</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:52:02.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404520040</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520040</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:50:11.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404520033</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520033</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:46:31.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404520026</udiDi>
    <basicUdiDi>89040452001RC</basicUdiDi>
    <tradeName>00890404520026</tradeName>
    <deviceName>INFUSION SET WITH AND WITHOUT VENT</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:20:27.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>26971810769914</udiDi>
    <basicUdiDi>697181076SYQ001RH</basicUdiDi>
    <tradeName>26971810769914</tradeName>
    <deviceName>Infusion Sets</deviceName>
    <manufacturerName>Shandong Wuzhou Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033372</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:57:39.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>16971810769917</udiDi>
    <basicUdiDi>697181076SYQ001RH</basicUdiDi>
    <tradeName>16971810769917</tradeName>
    <deviceName>Infusion Sets</deviceName>
    <manufacturerName>Shandong Wuzhou Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033372</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:50:04.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976574764027</udiDi>
    <basicUdiDi>06976574764KRFCVGR</basicUdiDi>
    <tradeName>PALEX</tradeName>
    <deviceName>INFUSION SET AUTO AIR-STOP</deviceName>
    <manufacturerName>Shandong Hapool Medical Technology Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037479</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRFCV</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:04:54.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6971077618624AN</udiDi>
    <basicUdiDi>B-6971077618624AN</basicUdiDi>
    <tradeName>D-6971077618624AN</tradeName>
    <deviceName>INFUSION SET</deviceName>
    <manufacturerName>ZIBO EASTMED HEALTHCARE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032259</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVDM018</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:47.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS407003-OC7</udiDi>
    <basicUdiDi>B-IS407003-OC7</basicUdiDi>
    <tradeName>INFUSET</tradeName>
    <deviceName>INFUSET - Deflussore microgoccia 3 vie</deviceName>
    <manufacturerName>Know Medical Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000013457</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS407003-O</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-20T20:01:59.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250132</udiDi>
    <basicUdiDi>622300425IVS1009Z3</basicUdiDi>
    <tradeName>ULTRAMED I.V. INFUSION SET With Flow Regulator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1013</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:44.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004250149</udiDi>
    <basicUdiDi>622300425IVS1009Z3</basicUdiDi>
    <tradeName>ULTRAMED I.V. INFUSION SET Micro Drip I.V.Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION MICRO-CONTROLLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:44.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251917</udiDi>
    <basicUdiDi>622300425IVS1009Z3</basicUdiDi>
    <tradeName>ULTRAMED I.V. INFUSION SET With Air-vented Spike</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1014</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:20.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046955293575</udiDi>
    <basicUdiDi>40392390000002942C</basicUdiDi>
    <tradeName>Dosifix®</tradeName>
    <deviceName>Dosifix G</deviceName>
    <manufacturerName>B. Braun Melsungen AG</manufacturerName>
    <manufacturerSrn>DE-MF-000000201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4037036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:32.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046955595662</udiDi>
    <basicUdiDi>40392390000002942C</basicUdiDi>
    <tradeName>Dosifix®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. Braun Melsungen AG</manufacturerName>
    <manufacturerSrn>DE-MF-000000201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4037038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:38:00.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6971077617429AF</udiDi>
    <basicUdiDi>B-6971077617429AF</basicUdiDi>
    <tradeName>D-6971077617429AF</tradeName>
    <deviceName>INFUSION SET</deviceName>
    <manufacturerName>ZIBO EASTMED HEALTHCARE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032259</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVDM018B</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:55:57.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6971077617423A3</udiDi>
    <basicUdiDi>B-6971077617423A3</basicUdiDi>
    <tradeName>D-6971077617423A3</tradeName>
    <deviceName>INFUSION SET</deviceName>
    <manufacturerName>ZIBO EASTMED HEALTHCARE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032259</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03010101</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH OR W/O AIR INLET</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVDM018B</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:55:54.226Z</lastUpdated>
  </row>
</eudamedExport>