<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SM8008TUT</udiDi>
    <basicUdiDi>B-SM8008TUT</basicUdiDi>
    <tradeName>D-SM8008TUT</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>SM8008T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:51.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM8008LUB</udiDi>
    <basicUdiDi>B-SM8008LUB</basicUdiDi>
    <tradeName>D-SM8008LUB</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>SM8008L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:47.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5060XLD9</udiDi>
    <basicUdiDi>B-SM5060XLD9</basicUdiDi>
    <tradeName>D-SM5060XLD9</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>SM5060XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:47.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5030XLCL</udiDi>
    <basicUdiDi>B-SM5030XLCL</basicUdiDi>
    <tradeName>D-SM5030XLCL</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>SM5030XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:46.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5030TTH</udiDi>
    <basicUdiDi>B-SM5030TTH</basicUdiDi>
    <tradeName>D-SM5030TTH</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>SM5030T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:45.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5030MT3</udiDi>
    <basicUdiDi>B-SM5030MT3</basicUdiDi>
    <tradeName>D-SM5030MT3</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>SM5030M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:41.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5030LSZ</udiDi>
    <basicUdiDi>B-SM5030LSZ</basicUdiDi>
    <tradeName>D-SM5030LSZ</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>SM5030L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:40.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5015XLCX</udiDi>
    <basicUdiDi>B-SM5015XLCX</basicUdiDi>
    <tradeName>D-SM5015XLCX</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>SM5015XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:39.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5015TTN</udiDi>
    <basicUdiDi>B-SM5015TTN</basicUdiDi>
    <tradeName>D-SM5015TTN</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>SM5015T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:38.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5015MT8</udiDi>
    <basicUdiDi>B-SM5015MT8</basicUdiDi>
    <tradeName>D-SM5015MT8</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>SM5015M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:34.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5015LT6</udiDi>
    <basicUdiDi>B-SM5015LT6</basicUdiDi>
    <tradeName>D-SM5015LT6</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>SM5015L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:34.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5008TTS</udiDi>
    <basicUdiDi>B-SM5008TTS</basicUdiDi>
    <tradeName>D-SM5008TTS</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>SM5008T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:33.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5008STQ</udiDi>
    <basicUdiDi>B-SM5008STQ</basicUdiDi>
    <tradeName>D-SM5008STQ</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>SM5008S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:32.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM5008LTA</udiDi>
    <basicUdiDi>B-SM5008LTA</basicUdiDi>
    <tradeName>D-SM5008LTA</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>SM5008L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:28.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM4060XLCU</udiDi>
    <basicUdiDi>B-SM4060XLCU</basicUdiDi>
    <tradeName>D-SM4060XLCU</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>SM4060XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:27.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM4030XLC7</udiDi>
    <basicUdiDi>B-SM4030XLC7</basicUdiDi>
    <tradeName>D-SM4030XLC7</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>SM4030XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:26.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM4030TT6</udiDi>
    <basicUdiDi>B-SM4030TT6</basicUdiDi>
    <tradeName>D-SM4030TT6</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>SM4030T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:26.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM4015XLCJ</udiDi>
    <basicUdiDi>B-SM4015XLCJ</basicUdiDi>
    <tradeName>D-SM4015XLCJ</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>SM4015XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:22.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM4015TTB</udiDi>
    <basicUdiDi>B-SM4015TTB</basicUdiDi>
    <tradeName>D-SM4015TTB</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>SM4015T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:21.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM4030MSQ</udiDi>
    <basicUdiDi>B-SM4030MSQ</basicUdiDi>
    <tradeName>D-SM4030MSQ</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>SM4030M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:44:20.540Z</lastUpdated>
  </row>
</eudamedExport>