<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06920756778715</udiDi>
    <basicUdiDi>69207567ZHZSQ00017B</basicUdiDi>
    <tradeName>Sterile Autodisable Syringe for single use(Plunger stop type,1mL,0.45mm)</tradeName>
    <deviceName>Sterile Autodisable Syringe for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD10F26</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:07:16.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920756761755</udiDi>
    <basicUdiDi>69207567YDSZSQ0001Y8</basicUdiDi>
    <tradeName>Sterile insulin syringe for single use Type 1 1ml  0.3mm×13mm(30G×1/2")</tradeName>
    <deviceName>Sterile insulin syringe for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010602</emdnCode>
    <emdnDescription>INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I103013</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:07:11.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920756710456</udiDi>
    <basicUdiDi>69207567ZSQ0001ZR</basicUdiDi>
    <tradeName>DR PROTECT</tradeName>
    <deviceName>Syringes for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010499</emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>s05l2330</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:07:04.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493101716</udiDi>
    <basicUdiDi>61924931ENTERALFEEDSYRBT</basicUdiDi>
    <tradeName>06192493101716</tradeName>
    <deviceName>ENTERAL FEEDING SYRINGES</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020108</emdnCode>
    <emdnDescription>ENTERAL FEEDING SYRINGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA001EN,  SA002EN, SA2,5EN, SA003EN, SA005EN, SA010EN , SA020EN, SA050EN, SA060EN, SA100EN</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:09.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493101624</udiDi>
    <basicUdiDi>61924931HYPOPENNEEDLES6P</basicUdiDi>
    <tradeName>06192493101624</tradeName>
    <deviceName>Aiguilles pour sylo insuline à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020108</emdnCode>
    <emdnDescription>ENTERAL FEEDING SYRINGES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>IPNEI-29G-13mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:08.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100771</udiDi>
    <basicUdiDi>61924931LLSYRINGESWNU5</basicUdiDi>
    <tradeName>SERINGUES 50ML LL SANS AIGUILLES</tradeName>
    <deviceName>Seringues Luer Lock, 3-pces sans aiguille, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH050LL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:55.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100764</udiDi>
    <basicUdiDi>61924931CATHSYRINGESWNNT</basicUdiDi>
    <tradeName>Seringues Cathéter, 3-pces sans aiguille, à usage unique</tradeName>
    <deviceName>Seringues Cathéter, 3-pces sans aiguille, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010203</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA050CT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:54.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100733</udiDi>
    <basicUdiDi>61924931LSSYRINGESWN2Z</basicUdiDi>
    <tradeName>06192493100733</tradeName>
    <deviceName>Seringues LS, 3-pces sans aiguille, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020101</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>SH010LS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:53.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100603</udiDi>
    <basicUdiDi>61924931LSSYRINGESWITHNDX</basicUdiDi>
    <tradeName>seringues 2ml</tradeName>
    <deviceName>Seringues LS, 3-pces avec aiguille</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH002LS23D/SH002LS23E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:49.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100566</udiDi>
    <basicUdiDi>61924931INSULINSYRINGES3Z</basicUdiDi>
    <tradeName>Seringues Insuline, à usage unique</tradeName>
    <deviceName>Seringues Insuline, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI001SE29B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:49.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100535</udiDi>
    <basicUdiDi>61924931TUBERCSYRINGES93</basicUdiDi>
    <tradeName>Seringue 1ml Tuberculine</tradeName>
    <deviceName>Seringue 1ml Tuberculine</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH001LS27B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:48.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100474</udiDi>
    <basicUdiDi>61924931LLSYRINGESWITHN4J</basicUdiDi>
    <tradeName>06192493100474</tradeName>
    <deviceName>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020101</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>SH010LL22F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:47.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06134473000169</udiDi>
    <basicUdiDi>6134473XXXXXXAAAAMMAAS1ZQ</basicUdiDi>
    <tradeName>PRONTO CICRETES</tradeName>
    <deviceName>Seringue stérile avec aiguille à usage unique</deviceName>
    <manufacturerName>SARL CICRETES</manufacturerName>
    <manufacturerSrn>DZ-MF-000031398</manufacturerSrn>
    <authorisedRepresentativeName>BERERHI ines</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000028806</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>20303 / 20310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:06.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>06118002224769</udiDi>
    <basicUdiDi>611800222SRGBLK4Z</basicUdiDi>
    <tradeName>SOLOJEKT</tradeName>
    <deviceName>Class I devices with a measuring function</deviceName>
    <manufacturerName>I'M Medicare SARL</manufacturerName>
    <manufacturerSrn>MA-MF-000037665</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT-17-00-BS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:49:51.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>06118002224127</udiDi>
    <basicUdiDi>611800222SYRINSBL</basicUdiDi>
    <tradeName>SOLOJEKT</tradeName>
    <deviceName>STERILE INSULIN SYRINGE</deviceName>
    <manufacturerName>I'M Medicare SARL</manufacturerName>
    <manufacturerSrn>MA-MF-000037665</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT-12-36-00</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:49:47.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>06118002221584</udiDi>
    <basicUdiDi>611800222HYPSYRWO2A</basicUdiDi>
    <tradeName>SOLOJEKT</tradeName>
    <deviceName>HYPODERMIC SYRINGE WITHOUT NEEDLE</deviceName>
    <manufacturerName>I'M Medicare SARL</manufacturerName>
    <manufacturerSrn>MA-MF-000037665</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT-03-00-LL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:49:45.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06118002220280</udiDi>
    <basicUdiDi>611800222ADRUPWO6M</basicUdiDi>
    <tradeName>SOLOJEKT AD</tradeName>
    <deviceName>AD/RUP SYRINGE WITHOUT NEEDLE</deviceName>
    <manufacturerName>I'M Medicare SARL</manufacturerName>
    <manufacturerSrn>MA-MF-000037665</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT-02-00-LL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:49:45.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>06118002221348</udiDi>
    <basicUdiDi>611800222HYPOSRGGD</basicUdiDi>
    <tradeName>SOLOJEKT</tradeName>
    <deviceName>HYPODERMIC SYRINGE</deviceName>
    <manufacturerName>I'M Medicare SARL</manufacturerName>
    <manufacturerSrn>MA-MF-000037665</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT-03-12-LS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:49:31.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>06118002220044</udiDi>
    <basicUdiDi>611800222ADRUPVZ</basicUdiDi>
    <tradeName>SOLOJEKT AD</tradeName>
    <deviceName>AD/RUP SYRINGE WITH NEEDLE</deviceName>
    <manufacturerName>I'M Medicare SARL</manufacturerName>
    <manufacturerSrn>MA-MF-000037665</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT-02-12-LS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:49:31.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06118002220013</udiDi>
    <basicUdiDi>611800222ADSFXV9</basicUdiDi>
    <tradeName>SOLOJEKT AD</tradeName>
    <deviceName>AD Syringe for fixed-dose immunization</deviceName>
    <manufacturerName>I'M Medicare SARL</manufacturerName>
    <manufacturerSrn>MA-MF-000037665</manufacturerSrn>
    <authorisedRepresentativeName>EUCEREP B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001966</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT-01-24-FX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:49:23.048Z</lastUpdated>
  </row>
</eudamedExport>