<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060912586707</udiDi>
    <basicUdiDi>B-05060912586707</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>05060912581726</udiDi>
    <basicUdiDi>50564696HoldersYR</basicUdiDi>
    <tradeName>Holder for Integrated Paragon Adult Oxygenator with 4000ml Reservoir</tradeName>
    <deviceName>Holder for Standalone Paragon Adult, Paediatric and Infant 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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMEH012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:02:34.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581658</udiDi>
    <basicUdiDi>50564696TPack2L</basicUdiDi>
    <tradeName>VAVD Tubing 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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CME95001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:02:33.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912580439</udiDi>
    <basicUdiDi>50564696TPackHaemo52</basicUdiDi>
    <tradeName>0.7 Pre-Connected Haemo 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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HAEMOFILTRATION-HAEMODIAFILTRATION KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CME90037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:02:32.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912580910</udiDi>
    <basicUdiDi>50564696PTAccVA</basicUdiDi>
    <tradeName>3m Water Line with Elbow Hanson Connectors</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-CM9261</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:02:31.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912580682</udiDi>
    <basicUdiDi>50564696TPackCPBPTS</basicUdiDi>
    <tradeName>Adult VAD 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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CME90048</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:02:30.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060491616987</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>High Flow Pigtail</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>MDR 2017/745</legislation>
    <emdnCode>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM5731</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:02:03.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060491610084</udiDi>
    <basicUdiDi>50564696TPackECK3</basicUdiDi>
    <tradeName>Infant ECMO 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>MDR 2017/745</legislation>
    <emdnCode>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CME90010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:02:03.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912580521</udiDi>
    <basicUdiDi>50564696TPackHaemo52</basicUdiDi>
    <tradeName>1.2 Haemoconcentrator 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>HAEMOFILTRATION-HAEMODIAFILTRATION KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CME90046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912580538</udiDi>
    <basicUdiDi>50564696TPackHaemo52</basicUdiDi>
    <tradeName>0.3 Haemoconcentrator Tubing 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>HAEMOFILTRATION-HAEMODIAFILTRATION KITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CME90047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581108</udiDi>
    <basicUdiDi>50564696PTAccVA</basicUdiDi>
    <tradeName>1.5m Blue Water Lines with Straight Hansen Connectors</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-CME90051</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581139</udiDi>
    <basicUdiDi>50564696PTAccVA</basicUdiDi>
    <tradeName>3/8" Male to Male Hansen Adapter</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-CME90054</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581177</udiDi>
    <basicUdiDi>50564696PTAccVA</basicUdiDi>
    <tradeName>Straight Hansen Connectors</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-CME90058</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581184</udiDi>
    <basicUdiDi>50564696PTAccVA</basicUdiDi>
    <tradeName>90o Hansen Connectors</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-CME90059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581320</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>High Flow Tap</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>CME90061</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581337</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>High Flow Pigtail</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>CME90062</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581429</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>Neonatal Bridge 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>CME57001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581733</udiDi>
    <basicUdiDi>50564696HoldersYR</basicUdiDi>
    <tradeName>Holder for Integrated Paragon Oxygenator</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMEH025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581740</udiDi>
    <basicUdiDi>50564696HoldersYR</basicUdiDi>
    <tradeName>Holder for Integrated Paragon Oxygenator with 1800ml Reservoir</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMEH042</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912581757</udiDi>
    <basicUdiDi>50564696HoldersYR</basicUdiDi>
    <tradeName>05060912581757</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMEH047</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:16.465Z</lastUpdated>
  </row>
</eudamedExport>