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    <tradeName>Membrane Oxygenator Adult</tradeName>
    <deviceName>Membrane Oxygenator 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>
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    <legislation>MDD</legislation>
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    <reference>617313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>07898716350013</udiDi>
    <basicUdiDi>B-07898716350013</basicUdiDi>
    <tradeName>Membrane Oxygenator Oxyprime 3000</tradeName>
    <deviceName>Membrane Oxygenator Oxyprime 3000</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
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    <emdnDescription>OXYGENATOR KITS</emdnDescription>
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    <udiDi>07898716350006</udiDi>
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    <tradeName>Membrane Oxygenator Oxyprime 7000</tradeName>
    <deviceName>Membrane Oxygenator Oxyprime 7000</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
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    <tradeName>Paragon Adult Maxi Integrated Oxygenator</tradeName>
    <deviceName>Paragon Adult Maxi Integrated Oxygenator</deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>Chalice Medical Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007891</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300PP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:26:12.000Z</lastUpdated>
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    <udiDi>08052705498288</udiDi>
    <basicUdiDi>805270549AG5304VM</basicUdiDi>
    <tradeName>SVR2000 AF PLUS</tradeName>
    <deviceName>SVR2000</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>AG5304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:34:18.349Z</lastUpdated>
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    <udiDi>18051160300706</udiDi>
    <basicUdiDi>8051160300198RZ</basicUdiDi>
    <tradeName>Quantum Perfusion</tradeName>
    <deviceName>Quantum Perfusion Blood oxygenator with integrated AF VT200-C2</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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT200-C2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:56:42.167Z</lastUpdated>
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    <udiDi>08051160300976</udiDi>
    <basicUdiDi>8051160300204R3</basicUdiDi>
    <tradeName>Quantum Perfusion</tradeName>
    <deviceName>Quantum Perfusion Blood Oxygenator Long Term VT200-E1L</deviceName>
    <manufacturerName>SPECTRUM MEDICAL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000009234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:54:58.807Z</lastUpdated>
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    <udiDi>08034013782921</udiDi>
    <basicUdiDi>803401378AG5000NL</basicUdiDi>
    <tradeName>A.L.ONE A.F. PLUS STERILE</tradeName>
    <deviceName>OXYGENATOR MODULE</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>AG5204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:23:47.365Z</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>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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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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    <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>
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    <emdnDescription>OXYGENATOR KITS</emdnDescription>
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    <reference>622276</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:18.185Z</lastUpdated>
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    <udiDi>07898716350747</udiDi>
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    <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>
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    <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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    <tradeName>Membrane Oxygenator Newborn 800 BRCoating</tradeName>
    <deviceName>Membrane Oxygenator Newborn 800 BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
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    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:13:05.387Z</lastUpdated>
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    <tradeName>Membrane Oxygenator Pediatric BRCoating</tradeName>
    <deviceName>Membrane Oxygenator Pediatric BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000016583</manufacturerSrn>
    <authorisedRepresentativeName>Mars Medical</authorisedRepresentativeName>
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    <emdnDescription>OXYGENATOR KITS</emdnDescription>
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    <tradeName>Membrane Oxygenator Infant 1500 BRCoating</tradeName>
    <deviceName>Membrane Oxygenator Infant 1500 BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
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    <emdnDescription>OXYGENATOR KITS</emdnDescription>
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    <lastUpdated>2026-07-03T04:13:03.794Z</lastUpdated>
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    <tradeName>Membrane Oxygenator Infant BRCoating</tradeName>
    <deviceName>Membrane Oxygenator Infant BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
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    <emdnDescription>OXYGENATOR KITS</emdnDescription>
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    <tradeName>Membrane Oxygenator Adult / BRV 4000 BRCoating</tradeName>
    <deviceName>Membrane Oxygenator Adult / BRV 4000 BRCoating</deviceName>
    <manufacturerName>Braile Biomédica Indústria Comércio e Representações Ltda.</manufacturerName>
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    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622378</reference>
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    <lastUpdated>2026-07-03T04:12:58.970Z</lastUpdated>
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