<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SD030560LKH</udiDi>
    <basicUdiDi>B-SD030560LKH</basicUdiDi>
    <tradeName>D-SD030560LKH</tradeName>
    <deviceName>Accufuser Omnibus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010202</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD030560L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:10:02.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST050715LVX</udiDi>
    <basicUdiDi>B-ST050715LVX</basicUdiDi>
    <tradeName>D-ST050715LVX</tradeName>
    <deviceName>Accufuser Omnibus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010202</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST050715L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:57.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NSE040830XLPK</udiDi>
    <basicUdiDi>B-NSE040830XLPK</basicUdiDi>
    <tradeName>D-NSE040830XLPK</tradeName>
    <deviceName>Accufuser Omnibus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010202</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NSE040830XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:54.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MP24830L8P</udiDi>
    <basicUdiDi>B-MP24830L8P</basicUdiDi>
    <tradeName>D-MP24830L8P</tradeName>
    <deviceName>Accufuser M8P</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010202</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP24830L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:50.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800331626212</udiDi>
    <basicUdiDi>B-08800331626212</basicUdiDi>
    <tradeName>Neofuser Plus</tradeName>
    <deviceName>Single Use Infusion Pump</deviceName>
    <manufacturerName>S&amp;S Med Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017308</manufacturerSrn>
    <authorisedRepresentativeName>Easy Medical Device</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000011902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I1501W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:48:10.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800331625291</udiDi>
    <basicUdiDi>B-08800331625291</basicUdiDi>
    <tradeName>Neofuser Plus</tradeName>
    <deviceName>Single Use Infusion Pump</deviceName>
    <manufacturerName>S&amp;S Med Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017308</manufacturerSrn>
    <authorisedRepresentativeName>Easy Medical Device</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000011902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I1507R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:48:10.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033055141307</udiDi>
    <basicUdiDi>B-08033055141307</basicUdiDi>
    <tradeName>HS VFUSER</tradeName>
    <deviceName>HS VFUSER</deviceName>
    <manufacturerName>H.S. Hospital Service S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000026770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INF06012-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:25:28.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050046231762</udiDi>
    <basicUdiDi>805004623ELASPUMP12TB</basicUdiDi>
    <tradeName>ELASPUMP</tradeName>
    <deviceName>POMPA ELASTOMERICA</deviceName>
    <manufacturerName>Multimedical s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000020128</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>093001/1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:51:06.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937401205489</udiDi>
    <basicUdiDi>697374067SZB-002WC</basicUdiDi>
    <tradeName>06937401205489</tradeName>
    <deviceName>Disposable infusion pump</deviceName>
    <manufacturerName>Zhejiang Runqiang Medical Instruments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000005693</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010202</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1727530280227</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:06:54.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260434710432</udiDi>
    <basicUdiDi>426043471CareVisSetYN</basicUdiDi>
    <tradeName>CareVis Set</tradeName>
    <deviceName>CareVis Set</deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000035547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CS.10.M2000.025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:18:59.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00851869007026</udiDi>
    <basicUdiDi>0851869007ENFUSECW</basicUdiDi>
    <tradeName>enFuse®</tradeName>
    <deviceName>enFuse®</deviceName>
    <manufacturerName>Enable Injections, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040157</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30129910</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:35:13.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>00085412487892</udiDi>
    <basicUdiDi>0085412GMN00000000002126Y</basicUdiDi>
    <tradeName>INTERMATE</tradeName>
    <deviceName>Intermate</deviceName>
    <manufacturerName>Baxter Healthcare SA</manufacturerName>
    <manufacturerSrn>CH-MF-000026124</manufacturerSrn>
    <authorisedRepresentativeName>Baxter Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2C2122K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:32:37.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>00085412081397</udiDi>
    <basicUdiDi>0085412GMN00000000002116W</basicUdiDi>
    <tradeName>INFUSOR</tradeName>
    <deviceName>Multirate Infusor</deviceName>
    <manufacturerName>Baxter Healthcare SA</manufacturerName>
    <manufacturerSrn>CH-MF-000026124</manufacturerSrn>
    <authorisedRepresentativeName>Baxter Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2C1154KP</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:32:30.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>00085412022512</udiDi>
    <basicUdiDi>0085412GMN00000000002106U</basicUdiDi>
    <tradeName>INFUSOR</tradeName>
    <deviceName>Infusor</deviceName>
    <manufacturerName>Baxter Healthcare SA</manufacturerName>
    <manufacturerSrn>CH-MF-000026124</manufacturerSrn>
    <authorisedRepresentativeName>Baxter Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>2C1008K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:32:29.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T8060L6D</udiDi>
    <basicUdiDi>B-T8060L6D</basicUdiDi>
    <tradeName>D-T8060L6D</tradeName>
    <deviceName>Accufuser Plus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T8060L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:24.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T8030XLMJ</udiDi>
    <basicUdiDi>B-T8030XLMJ</basicUdiDi>
    <tradeName>D-T8030XLMJ</tradeName>
    <deviceName>Accufuser Plus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T8030XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:23.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T8060XLN7</udiDi>
    <basicUdiDi>B-T8060XLN7</basicUdiDi>
    <tradeName>D-T8060XLN7</tradeName>
    <deviceName>Accufuser Plus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T8060XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:21.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T8030L5W</udiDi>
    <basicUdiDi>B-T8030L5W</basicUdiDi>
    <tradeName>D-T8030L5W</tradeName>
    <deviceName>Accufuser Plus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T8030L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:04.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T8015XLMV</udiDi>
    <basicUdiDi>B-T8015XLMV</basicUdiDi>
    <tradeName>D-T8015XLMV</tradeName>
    <deviceName>Accufuser Plus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T8015XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:03.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T8015L63</udiDi>
    <basicUdiDi>B-T8015L63</basicUdiDi>
    <tradeName>D-T8015L63</tradeName>
    <deviceName>Accufuser Plus</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A05010102</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T8015L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:03.029Z</lastUpdated>
  </row>
</eudamedExport>