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<eudamedExport entity="devices">
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    <udiDi>05413206346110</udiDi>
    <basicUdiDi>5413206KNASX6</basicUdiDi>
    <tradeName>K-Pack Embrace Active Safety Needle</tradeName>
    <deviceName>K-Pack Embrace Active Safety Needle</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010101</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KNAS-2516RB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:53:02.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206222445</udiDi>
    <basicUdiDi>5413206SG39W</basicUdiDi>
    <tradeName>SurGuard3 Safety Hypodermic Needle</tradeName>
    <deviceName>SurGuard3 Safety Hypodermic Needle</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010101</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG3-1925RB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:58.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206346042</udiDi>
    <basicUdiDi>5413206KHPY</basicUdiDi>
    <tradeName>K-Pack Enhance Needle</tradeName>
    <deviceName>K-Pack Enhance Needle</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KH-2713RBBTC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:57.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206251223</udiDi>
    <basicUdiDi>5413206NFQ5</basicUdiDi>
    <tradeName>Terumo Injection Filter Needle</tradeName>
    <deviceName>Terumo Injection Filter Needle</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010599</emdnCode>
    <emdnDescription>OPHTHALMOLOGY INJECTION NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NF-3013RBKE05M</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:55.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206220953</udiDi>
    <basicUdiDi>5413206UMTCS</basicUdiDi>
    <tradeName>Ultimaster Tansei</tradeName>
    <deviceName>Ultimaster Tansei Sirolimus eluting coronary stent system</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-RQ2512KSM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:53.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206055906</udiDi>
    <basicUdiDi>5413206SVSWLZ2</basicUdiDi>
    <tradeName>Surflo Winged Infusion Set with Needle Protection (Surshield)</tradeName>
    <deviceName>Surflo Winged Infusion Set with Needle Protection (Surshield)</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010201</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SV-S23WL35</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:52.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206054923</udiDi>
    <basicUdiDi>5413206SVSFLXF</basicUdiDi>
    <tradeName>Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A01010201</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SV-S23FL35</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:51.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206054886</udiDi>
    <basicUdiDi>5413206SVSBLX3</basicUdiDi>
    <tradeName>Surflo Winged Infusion Set with Needle Protection (Surshield)</tradeName>
    <deviceName>Surflo Winged Infusion Set with Needle Protection (Surshield)</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010201</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SV-S23BL35</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:50.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206026661</udiDi>
    <basicUdiDi>5413206TRICE</basicUdiDi>
    <tradeName>RADIFOCUS Introducer II</tradeName>
    <deviceName>RADIFOCUS Introducer II</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-R40G07PQ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:50.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206004577</udiDi>
    <basicUdiDi>5413206NNQM</basicUdiDi>
    <tradeName>Neolus Needle</tradeName>
    <deviceName>Neolus Needle</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NN-1925R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:46.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206035625</udiDi>
    <basicUdiDi>5413206BSN9Z</basicUdiDi>
    <tradeName>TERUMO SYRINGE with Fixed Needle Menopur Multidose 600 IU/ml FSH/LH</tradeName>
    <deviceName>Terumo Syringe with Fixed Needle</deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-N1G2913</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:50:41.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206342440</udiDi>
    <basicUdiDi>5413206BSN9Z</basicUdiDi>
    <tradeName>TERUMO SYRINGE with Fixed Needle for 1 mg/0.2 ml leuprolide acetate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-N1L2713</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:44:12.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206052486</udiDi>
    <basicUdiDi>5413206BSN9Z</basicUdiDi>
    <tradeName>TERUMO SYRINGE with Fixed Needle 600 IU/ml FSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-N1A2713</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:43:58.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206220229</udiDi>
    <basicUdiDi>5413206BSN9Z</basicUdiDi>
    <tradeName>TERUMO SYRINGE with Fixed Needle GONAL-f Multi-Dose 1050 IU/1.75 ml 450 IU/0.75 ml (follitropin alfa for injection)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-N1A2713E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:43:58.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206220243</udiDi>
    <basicUdiDi>5413206BSN9Z</basicUdiDi>
    <tradeName>TERUMO SYRINGE with Fixed Needle For use only with GONAL-F Multi-Dose 600 IU/ml  (follitropin alfa for injection)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>BS-N1A2713U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:43:58.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206210497</udiDi>
    <basicUdiDi>5413206BSN9Z</basicUdiDi>
    <tradeName>TERUMO SYRINGE with Fixed Needle Folisurge 600 IU/0.96 ml FSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020199</emdnCode>
    <emdnDescription>SYRINGES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-N1A2713FI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:43:58.631Z</lastUpdated>
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  <row>
    <udiDi>05413206210923</udiDi>
    <basicUdiDi>5413206BSN9Z</basicUdiDi>
    <tradeName>TERUMO SYRINGE with Fixed Needle 600 IU/ml FSH/LH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>BS-N1G2913K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:43:58.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206214914</udiDi>
    <basicUdiDi>5413206SVSFLXF</basicUdiDi>
    <tradeName>Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A01010201</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>SV-S25FL35C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:43:17.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206346127</udiDi>
    <basicUdiDi>5413206KNASX6</basicUdiDi>
    <tradeName>K-Pack Embrace Active Safety Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010101</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KNAS-2525RB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:43:45.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>05413206026692</udiDi>
    <basicUdiDi>5413206TRICE</basicUdiDi>
    <tradeName>RADIFOCUS Introducer II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TERUMO EUROPE N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-R50A10PQ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:43:33.737Z</lastUpdated>
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</eudamedExport>