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    <basicUdiDi>B-08033178397988</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>IN02859H 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>IN02859H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:03:01.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033178397919</udiDi>
    <basicUdiDi>B-08033178397919</basicUdiDi>
    <tradeName>PTS</tradeName>
    <deviceName>NL BREDA</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>AB5023</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:03:00.811Z</lastUpdated>
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    <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>
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    <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>07898716350297</udiDi>
    <basicUdiDi>B-07898716350297</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Newborn</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:42.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350280</udiDi>
    <basicUdiDi>B-07898716350280</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Paediatric</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:41.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350273</udiDi>
    <basicUdiDi>B-07898716350273</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Infant 1500</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:40.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350266</udiDi>
    <basicUdiDi>B-07898716350266</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Infant</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617309</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:40.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350259</udiDi>
    <basicUdiDi>B-07898716350259</basicUdiDi>
    <tradeName>Cardiopulmonary Bypass Kit Adult</tradeName>
    <deviceName>Cardiopulmonary Bypass Kit 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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617308</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:36.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350242</udiDi>
    <basicUdiDi>B-07898716350242</basicUdiDi>
    <tradeName>Blood Reservoir Cardiotomy 500</tradeName>
    <deviceName>Blood Reservoir Cardiotomy 500</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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617335</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:35.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350235</udiDi>
    <basicUdiDi>B-07898716350235</basicUdiDi>
    <tradeName>Blood Reservoir Cardiotomy 2000</tradeName>
    <deviceName>Blood Reservoir Cardiotomy 2000</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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617334</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:34.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350228</udiDi>
    <basicUdiDi>B-07898716350228</basicUdiDi>
    <tradeName>Blood Reservoir Cardiotomy 4000</tradeName>
    <deviceName>Blood Reservoir Cardiotomy 4000</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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617333</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:33.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350211</udiDi>
    <basicUdiDi>B-07898716350211</basicUdiDi>
    <tradeName>Blood Reservoir Venous 500</tradeName>
    <deviceName>Blood Reservoir Venous 500</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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:28.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350204</udiDi>
    <basicUdiDi>B-07898716350204</basicUdiDi>
    <tradeName>Blood Reservoir Venous 2000</tradeName>
    <deviceName>Blood Reservoir Venous 2000</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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617331</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:28.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>07898716350198</udiDi>
    <basicUdiDi>B-07898716350198</basicUdiDi>
    <tradeName>Blood Reservoir Venous 4000</tradeName>
    <deviceName>Blood Reservoir Venous 4000</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>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:27.236Z</lastUpdated>
  </row>
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    <udiDi>07898716350181</udiDi>
    <basicUdiDi>B-07898716350181</basicUdiDi>
    <tradeName>Tubing Set ECMO Newborn</tradeName>
    <deviceName>Tubing Set ECMO 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>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:26.779Z</lastUpdated>
  </row>
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    <udiDi>07898716350174</udiDi>
    <basicUdiDi>B-07898716350174</basicUdiDi>
    <tradeName>Tubing Set ECMO Infant</tradeName>
    <deviceName>Tubing Set ECMO 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>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>617328</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:16:21.630Z</lastUpdated>
  </row>
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