<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033178398107</udiDi>
    <basicUdiDi>B-08033178398107</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>BG SOFIA</deviceName>
    <manufacturerName>Sorin Group Italia S.r.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000027510</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB5032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:03:00.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033178397995</udiDi>
    <basicUdiDi>B-08033178397995</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>IN02860H FI OULU</deviceName>
    <manufacturerName>Sorin Group Italia S.r.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000027510</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN02860H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:02:59.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033178397834</udiDi>
    <basicUdiDi>B-08033178397834</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>C24784 DK AARHUS</deviceName>
    <manufacturerName>Sorin Group Italia S.r.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000027510</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C24784</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:02:42.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033178397315</udiDi>
    <basicUdiDi>B-08033178397315</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>IN02183 FR TOURS *      PHISIO</deviceName>
    <manufacturerName>Sorin Group Italia S.r.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000027510</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN02183</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:02:41.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033178351140</udiDi>
    <basicUdiDi>B-08033178351140</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>DE BERLIN</deviceName>
    <manufacturerName>Sorin Group Italia S.r.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000027510</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2492</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:02:40.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350150</udiDi>
    <basicUdiDi>B-07898716350150</basicUdiDi>
    <tradeName>Tubing Set Newborn</tradeName>
    <deviceName>Tubing Set Newborn</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617326</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:20.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350143</udiDi>
    <basicUdiDi>B-07898716350143</basicUdiDi>
    <tradeName>Tubing Set Paediatric</tradeName>
    <deviceName>Tubing Set Paediatric</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:19.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350136</udiDi>
    <basicUdiDi>B-07898716350136</basicUdiDi>
    <tradeName>Tubing Set Infant 1500</tradeName>
    <deviceName>Tubing Set Infant 1500</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617324</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:18.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350129</udiDi>
    <basicUdiDi>B-07898716350129</basicUdiDi>
    <tradeName>Tubing Set Infant</tradeName>
    <deviceName>Tubing Set Infant</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:13.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350112</udiDi>
    <basicUdiDi>B-07898716350112</basicUdiDi>
    <tradeName>Tubing Set Adult</tradeName>
    <deviceName>Tubing Set Adult</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:12.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>18051160303066</udiDi>
    <basicUdiDi>8051160300273RN</basicUdiDi>
    <tradeName>Quantum SuperPac</tradeName>
    <deviceName>Quantum SuperPAC CPB - 1/2 Venous</deviceName>
    <manufacturerName>SPECTRUM MEDICAL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000009234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC200A-D1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:56:54.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>18051160302915</udiDi>
    <basicUdiDi>8051160300280RK</basicUdiDi>
    <tradeName>Quantum SuperPAC</tradeName>
    <deviceName>Quantum SuperPAC Long Term - High Flow</deviceName>
    <manufacturerName>SPECTRUM MEDICAL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000009234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPE200F-B1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:56:54.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>18051160302700</udiDi>
    <basicUdiDi>8051160300105QY</basicUdiDi>
    <tradeName>Quantum SuperPac</tradeName>
    <deviceName>Quantum SuperPac Long Term High Flow Tubing Set - SP05E-A0</deviceName>
    <manufacturerName>SPECTRUM MEDICAL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000009234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP05E-A0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:56:49.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772326544</udiDi>
    <basicUdiDi>803377232HMC-SET-ETO-Z8</basicUdiDi>
    <tradeName>DP 03 Hemoconcentrator set</tradeName>
    <deviceName>SETS FOR HEMOCONCENTRATION DEVICES</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M90006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:36.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405298</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-102 EX Adult</tradeName>
    <deviceName>Tubing Set BPM</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>622578</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:15:58.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350792</udiDi>
    <basicUdiDi>78987163562230269</basicUdiDi>
    <tradeName>Tubing Set Newborn BRCoating</tradeName>
    <deviceName>Tubing Set Newborn BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622302</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:17.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350785</udiDi>
    <basicUdiDi>7898716356222987B</basicUdiDi>
    <tradeName>Tubing Set Pediatric BRCoating</tradeName>
    <deviceName>Tubing Set Pediatric BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622298</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:16.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350778</udiDi>
    <basicUdiDi>78987163562229473</basicUdiDi>
    <tradeName>Tubing Set Infant 1500 BRCoating</tradeName>
    <deviceName>Tubing Set Infant 1500 BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622294</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:12.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350761</udiDi>
    <basicUdiDi>7898716356222906T</basicUdiDi>
    <tradeName>Tubing Set Infant BRCoating</tradeName>
    <deviceName>Tubing Set Infant BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622290</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:11.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350754</udiDi>
    <basicUdiDi>78987163562228674</basicUdiDi>
    <tradeName>Tubing Set Adult BRCoating</tradeName>
    <deviceName>Tubing Set Adult BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006312</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010101</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622286</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:10.971Z</lastUpdated>
  </row>
</eudamedExport>