<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06941617116958</udiDi>
    <basicUdiDi>693811937463K7</basicUdiDi>
    <tradeName>06941617116958</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMCBI41002L12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T06:49:18.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941617116965</udiDi>
    <basicUdiDi>693811937463K7</basicUdiDi>
    <tradeName>06941617116965</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMCBI41003L12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T06:49:18.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941617116972</udiDi>
    <basicUdiDi>693811937463K7</basicUdiDi>
    <tradeName>06941617116972</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMCBI42752L12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T06:49:18.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260434710401</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>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CS.00.VX214</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:52:07.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016775602</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775602</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-R02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016775770</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775770</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016775787</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775787</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-0R05</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016776135</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016776135</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-S2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016776142</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016776142</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016776159</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016776159</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-07</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016780064</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016780064</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016780095</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016780095</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938016780101</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016780101</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-05</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.745Z</lastUpdated>
  </row>
  <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>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>D-ST_50160LKC</udiDi>
    <basicUdiDi>B-ST_50160LKC</basicUdiDi>
    <tradeName>D-ST_50160LKC</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>ST_50160L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:46:01.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST_50130LJV</udiDi>
    <basicUdiDi>B-ST_50130LJV</basicUdiDi>
    <tradeName>D-ST_50130LJV</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>ST_50130L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:45:59.142Z</lastUpdated>
  </row>
</eudamedExport>