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    <udiDi>08034013780330</udiDi>
    <basicUdiDi>803401378EU5019VP</basicUdiDi>
    <tradeName>A.L.ONE ECMO STERILE</tradeName>
    <deviceName>A.L.ONE ECMO STERILE</deviceName>
    <manufacturerName>EUROSETS S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000023171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU5019</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:23:22.472Z</lastUpdated>
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    <udiDi>08034013780002</udiDi>
    <basicUdiDi>803401378AG5300P3</basicUdiDi>
    <tradeName>SKIPPER STERILE</tradeName>
    <deviceName>OXYGENATOR INTEGRATED WITH HEAT EXCHANGER AND CVR</deviceName>
    <manufacturerName>EUROSETS S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000023171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU5007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:23:16.864Z</lastUpdated>
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    <udiDi>08033772329804</udiDi>
    <basicUdiDi>803377232OXY-SET-HEPAZ</basicUdiDi>
    <tradeName>Single line for portal vein perfusion with oxygenator D150</tradeName>
    <deviceName>OXYGENATION DEVICES FOR LIVER ARTEY AND PORTAL VEIN PERFUSION</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0399</emdnCode>
    <emdnDescription>CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O2-SMART150PL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:48.995Z</lastUpdated>
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    <udiDi>08033772329798</udiDi>
    <basicUdiDi>803377232OXY-SET-KIDB4</basicUdiDi>
    <tradeName>Single line for kidney artery perfusion with oxygenator D150</tradeName>
    <deviceName>OXYGENATION DEVICES FOR KIDNEY ARTEY PERFUSION</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0399</emdnCode>
    <emdnDescription>CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O2-SMART150K</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:45.004Z</lastUpdated>
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    <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>
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    <udiDi>08033772326216</udiDi>
    <basicUdiDi>803377232HMC-ETO-K6</basicUdiDi>
    <tradeName>Emoconcentratore DP03HC - EO / DP03HC - EO Hemoconcentrator</tradeName>
    <deviceName>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>C03010104</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M03957</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:36.330Z</lastUpdated>
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    <udiDi>08033772322713</udiDi>
    <basicUdiDi>803377232HMC-RAY-KY</basicUdiDi>
    <tradeName>Emoconcentratore D050 con 2 valvole e 3 vie / D050 Hemoconcentrator with n°2 valves and 3 ways</tradeName>
    <deviceName>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>C03010104</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M03662</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:20.930Z</lastUpdated>
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  <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>07898716350822</udiDi>
    <basicUdiDi>7898716356222806Q</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Infant 1500 BRCoating</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622280</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:39.071Z</lastUpdated>
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    <udiDi>07898716350846</udiDi>
    <basicUdiDi>7898716356222846Y</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Newborn BRCoating</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622284</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:36.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350839</udiDi>
    <basicUdiDi>7898716356222826U</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Pediatric BRCoating</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622282</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:35.979Z</lastUpdated>
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    <udiDi>07898716350815</udiDi>
    <basicUdiDi>78987163562227875</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Infant BRCoating</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622278</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:19.869Z</lastUpdated>
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    <udiDi>07898716350808</udiDi>
    <basicUdiDi>7898716356222766Z</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Adult BRCoating</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622276</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:18.185Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>07898716350747</udiDi>
    <basicUdiDi>7898716356223816X</basicUdiDi>
    <tradeName>Membrane Oxygenator Newborn 800 / BRV 500 BRCoating</tradeName>
    <deviceName>Membrane Oxygenator Newborn 800 / BRV 500 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622381</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:10.175Z</lastUpdated>
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    <udiDi>07898716350730</udiDi>
    <basicUdiDi>7898716356222716P</basicUdiDi>
    <tradeName>Membrane Oxygenator Newborn 800 BRCoating</tradeName>
    <deviceName>Membrane Oxygenator Newborn 800 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622271</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:05.387Z</lastUpdated>
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