<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060434424105</udiDi>
    <basicUdiDi>506043442QMPDM6W</basicUdiDi>
    <tradeName>05060434424105</tradeName>
    <deviceName>Quantum Mini Pump Drive Module</deviceName>
    <manufacturerName>Spectrum Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033594</manufacturerSrn>
    <authorisedRepresentativeName>Spectrum Medical S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000045914</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51-000160-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:45:48.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260090041840</udiDi>
    <basicUdiDi>4260090042540QK</basicUdiDi>
    <tradeName>04260090041840</tradeName>
    <deviceName>EXCOR Active driving unit</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1502200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:49.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260090040652</udiDi>
    <basicUdiDi>4260090042496R9</basicUdiDi>
    <tradeName>04260090040652</tradeName>
    <deviceName>Stationary driving unit Ikus Rev. 2.1</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D03I-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:48.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033817901099</udiDi>
    <basicUdiDi>B-04033817901099</basicUdiDi>
    <tradeName>Heater Cooler System Stockert 3T</tradeName>
    <deviceName>Heater Cooler System Stockert 3T</deviceName>
    <manufacturerName>LivaNova Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000014243</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16-02-80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:25:41.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>B009OCSLungConsoleGY</udiDi>
    <basicUdiDi>++B009OCSLungConsoleGY</basicUdiDi>
    <tradeName>B009OCSLungConsoleGY</tradeName>
    <deviceName>OCS Lung Console</deviceName>
    <manufacturerName>TransMedics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000029912</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:28.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>B009OCSHeartConsole2E</udiDi>
    <basicUdiDi>++B009OCSHeartConsole2E</basicUdiDi>
    <tradeName>B009OCSHeartConsole2E</tradeName>
    <deviceName>OCS Heart Console</deviceName>
    <manufacturerName>TransMedics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000029912</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100004929</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:16.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>04058863314747</udiDi>
    <basicUdiDi>405886331474D7</basicUdiDi>
    <tradeName>Cardiohelp II Base Unit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maquet Cardiopulmonary GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701077135</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:37:01.217Z</lastUpdated>
  </row>
</eudamedExport>