<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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></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></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>05060912587940</udiDi>
    <basicUdiDi>50564696TPackHaemo52</basicUdiDi>
    <tradeName>0.7 Haemoconcentrator Tubing Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOFILTRATION-HAEMODIAFILTRATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME90023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:15.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912587957</udiDi>
    <basicUdiDi>50564696TPackctQ6</basicUdiDi>
    <tradeName>Coated Lineas CEC 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></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCME54003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:15.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912587988</udiDi>
    <basicUdiDi>50564696TPackECK3</basicUdiDi>
    <tradeName>Adult ECMO Tubing Pack without Oxy</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM5740</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:15.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912587995</udiDi>
    <basicUdiDi>50564696TPackHaemo52</basicUdiDi>
    <tradeName>0.7 Haemo Tubing Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOFILTRATION-HAEMODIAFILTRATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM5741</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588022</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>Spare Lines</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME72012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.948Z</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></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>05060912588114</udiDi>
    <basicUdiDi>B-05060912588114</basicUdiDi>
    <tradeName>Paragon Adult Midi PP 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></emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP260PP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588213</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>Aspiradores CEC Tubing Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME54004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588220</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>1/2 x 3/8 Tubing Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME54005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588237</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>3/8 x 3/8 Tubing Pack</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME54006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588299</udiDi>
    <basicUdiDi>50564696TPack2L</basicUdiDi>
    <tradeName>Cardioplegia Set</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CME41005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.785Z</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></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>05060912588435</udiDi>
    <basicUdiDi>B-05060912588435</basicUdiDi>
    <tradeName>Paragon Adult Midi Integrated Oxygenator with MicroNet Filter</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></emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI260MN</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588442</udiDi>
    <basicUdiDi>B-05060912588442</basicUdiDi>
    <tradeName>Paragon Adult Midi Integrated 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></emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI260PP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588459</udiDi>
    <basicUdiDi>B-05060912588459</basicUdiDi>
    <tradeName>Paragon Adult Maxi Integrated 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></emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300MN</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588466</udiDi>
    <basicUdiDi>B-05060912588466</basicUdiDi>
    <tradeName>Paragon Adult Maxi Integrated 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></emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300PP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588497</udiDi>
    <basicUdiDi>B-05060912588497</basicUdiDi>
    <tradeName>Paragon Adult Midi 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></emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP265PMP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588503</udiDi>
    <basicUdiDi>B-05060912588503</basicUdiDi>
    <tradeName>Paragon Adult Maxi 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></emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP305PMP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:14.617Z</lastUpdated>
  </row>
</eudamedExport>