<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033772328234</udiDi>
    <basicUdiDi>803377232HMC-RAY-KY</basicUdiDi>
    <tradeName>Emoconcentratore D200 / D200 Hemoconcentrator</tradeName>
    <deviceName></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>M03099</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:45:34.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772329132</udiDi>
    <basicUdiDi>803377232HMC-RAY-KY</basicUdiDi>
    <tradeName>Emoconcentratore D300 / D300 Hemoconcentrator</tradeName>
    <deviceName></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>M03100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:45:21.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772328210</udiDi>
    <basicUdiDi>803377232HMC-RAY-KY</basicUdiDi>
    <tradeName>Emoconcentratore D050 / D050 Hemoconcentrator</tradeName>
    <deviceName></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>M03665</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:43:43.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772325998</udiDi>
    <basicUdiDi>803377232HMC-RAY-KY</basicUdiDi>
    <tradeName>Emoconcentratore D025 / D025 Hemoconcentrator</tradeName>
    <deviceName></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>M03956</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:42:53.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912585588</udiDi>
    <basicUdiDi>50564696TpackECoxG9</basicUdiDi>
    <tradeName>ECMO Tubing Pack with Adult Midi Paragon PMP Oxygenator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME90006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:15.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912587797</udiDi>
    <basicUdiDi>50564696TpackECoxG9</basicUdiDi>
    <tradeName>ECMO Tubing Pack with Infant Paragon PMP Oxygenator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CME90003</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:15.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912587803</udiDi>
    <basicUdiDi>50564696TpackECoxG9</basicUdiDi>
    <tradeName>ECMO Tubing Pack with Neonatal Paragon PMP Oxygenator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME90004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:15.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912587889</udiDi>
    <basicUdiDi>50564696TPackECctox7B</basicUdiDi>
    <tradeName>Adult ECLS/ECMO Tubing Pack - Coated</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCME14011</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:15.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588053</udiDi>
    <basicUdiDi>50564696TpackECoxG9</basicUdiDi>
    <tradeName>CMO8 Adult PMP Oxygenator with Tubing Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME90086</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588350</udiDi>
    <basicUdiDi>50564696TpackECoxG9</basicUdiDi>
    <tradeName>ECMO Tubing Pack with Infant Paragon PMP Oxygenator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME90003</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588527</udiDi>
    <basicUdiDi>50564696TpackECoxG9</basicUdiDi>
    <tradeName>Haemoperfusion Tubing Pack with Neonatal PMP Oxygenator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chalice Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010617</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME72003</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974762682061</udiDi>
    <basicUdiDi>697476268-BGEA-DP</basicUdiDi>
    <tradeName>Lifemotion Disposable Membrane Oxygenator-500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifemotion Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043705</manufacturerSrn>
    <authorisedRepresentativeName>LIFEMOTION S.R.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000029834</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LM-BGEA-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:50:56.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974762682221</udiDi>
    <basicUdiDi>697476268-BGEA-DP</basicUdiDi>
    <tradeName>Lifemotion Standalone Oxygenator Holder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifemotion Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043705</manufacturerSrn>
    <authorisedRepresentativeName>LIFEMOTION S.R.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000029834</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LMF-13-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:50:56.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405304</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-103 EX Adult</tradeName>
    <deviceName></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>622582</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:28:43.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405311</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-301 EX Infant</tradeName>
    <deviceName></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>622589</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:28:43.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405328</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-302 EX Infant</tradeName>
    <deviceName></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>622597</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:28:43.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405335</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-303 EX Infant</tradeName>
    <deviceName></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>622603</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:28:43.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405342</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-501 EX Newborn</tradeName>
    <deviceName></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>622687</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:28:43.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405359</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-502 EX Newborn</tradeName>
    <deviceName></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>622695</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:28:43.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>07908831405366</udiDi>
    <basicUdiDi>789871635TSBPM3L</basicUdiDi>
    <tradeName>Tubing Set BPM-503 EX Newborn</tradeName>
    <deviceName></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>622701</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:28:43.276Z</lastUpdated>
  </row>
</eudamedExport>