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    <tradeName>Paragon Adult Maxi Integrated Oxygenator with MicroNet Filter</tradeName>
    <deviceName>Paragon Adult Maxi Integrated Oxygenator with MicroNet filter</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300MN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:28.371Z</lastUpdated>
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    <udiDi>05060912588756</udiDi>
    <basicUdiDi>B-05060912588756</basicUdiDi>
    <tradeName>Paragon Adult Midi Integrated Oxygenator</tradeName>
    <deviceName>Paragon Adult Midi Integrated Oxygenator</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI260MN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:24.373Z</lastUpdated>
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  <row>
    <udiDi>05060912588749</udiDi>
    <basicUdiDi>B-05060912588749</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>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300PP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:23.567Z</lastUpdated>
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  <row>
    <udiDi>05060912588503</udiDi>
    <basicUdiDi>B-05060912588503</basicUdiDi>
    <tradeName>Paragon Adult Maxi PMP Oxygenator</tradeName>
    <deviceName>Paragon Adult Maxi PMP Oxygenator</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP305PMP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:22.786Z</lastUpdated>
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  <row>
    <udiDi>05060912588497</udiDi>
    <basicUdiDi>B-05060912588497</basicUdiDi>
    <tradeName>Paragon Adult Midi PMP Oxygenator</tradeName>
    <deviceName>Paragon Adult Midi PMP Oxygenator</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP265PMP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:21.983Z</lastUpdated>
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  <row>
    <udiDi>05060912588466</udiDi>
    <basicUdiDi>B-05060912588466</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>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>2026-08-02T15:39:17.962Z</lastUpdated>
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    <udiDi>05060912588459</udiDi>
    <basicUdiDi>B-05060912588459</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>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300MN</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:17.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588442</udiDi>
    <basicUdiDi>B-05060912588442</basicUdiDi>
    <tradeName>Paragon Adult Midi Integrated Oxygenator</tradeName>
    <deviceName>Paragon Adult Midi Integrated Oxygenator</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI260PP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:16.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588435</udiDi>
    <basicUdiDi>B-05060912588435</basicUdiDi>
    <tradeName>Paragon Adult Midi Integrated Oxygenator with MicroNet Filter</tradeName>
    <deviceName>Paragon Adult Midi Integrated Oxygenator with MicroNet Filter</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI260MN</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:15.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912588114</udiDi>
    <basicUdiDi>B-05060912588114</basicUdiDi>
    <tradeName>Paragon Adult Midi PP Oxygenator</tradeName>
    <deviceName>Paragon Adult Midi PP Oxygenator</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOP260PP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:11.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912586745</udiDi>
    <basicUdiDi>B-05060912586745</basicUdiDi>
    <tradeName>Paragon Infant Integrated Oxygenator</tradeName>
    <deviceName>Paragon Infant 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>XCMOPI140PP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:10.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912586738</udiDi>
    <basicUdiDi>B-05060912586738</basicUdiDi>
    <tradeName>Paragon Infant Micronet Integrated Oxygenator</tradeName>
    <deviceName>Paragon Infant MicroNet 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>XCMOPI140MN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:09.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912586721</udiDi>
    <basicUdiDi>B-05060912586721</basicUdiDi>
    <tradeName>Paragon Adult Midi Integrated Oxygenator</tradeName>
    <deviceName>Paragon Adult Midi 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>XCMOPI260PP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:09.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912586714</udiDi>
    <basicUdiDi>B-05060912586714</basicUdiDi>
    <tradeName>Paragon Adult Midi Integrated Oxygenator with Micronet Filter</tradeName>
    <deviceName>Paragon Adult Midi Integrated Oxygenator with Micronet Filter</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>XCMOPI260MN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:05.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912586653</udiDi>
    <basicUdiDi>B-05060912586653</basicUdiDi>
    <tradeName>Paragon Adult Maxi Integrated Oxygenator with Micronet Filter</tradeName>
    <deviceName>Paragon Adult Maxi Integrated Oxygenator with Micronet Filter</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>XCMOPI300MN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:04.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060912585304</udiDi>
    <basicUdiDi>B-05060912585304</basicUdiDi>
    <tradeName>ECMO Tubing Pack with Infant Paragon PMP 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CME90003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:03.569Z</lastUpdated>
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    <udiDi>05060912581818</udiDi>
    <basicUdiDi>B-05060912581818</basicUdiDi>
    <tradeName>Paragon Adult PP Oxygenator</tradeName>
    <deviceName>Paragon Adult PP 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>XCMOP300PP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:02.751Z</lastUpdated>
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    <udiDi>05060491617533</udiDi>
    <basicUdiDi>B-05060491617533</basicUdiDi>
    <tradeName>05060491617533</tradeName>
    <deviceName>Paragon Adult Midi Integrated Oxygenator</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI260PP</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:38:01.033Z</lastUpdated>
  </row>
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    <udiDi>05060491618790</udiDi>
    <basicUdiDi>B-05060491618790</basicUdiDi>
    <tradeName>05060491618790</tradeName>
    <deviceName>Paragon Adult Maxi Integrated Oxygenator</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI300PP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:57.843Z</lastUpdated>
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    <udiDi>05060491617489</udiDi>
    <basicUdiDi>B-05060491617489</basicUdiDi>
    <tradeName>05060491617489</tradeName>
    <deviceName>Adult Midi Integrated Oxygenator with MicroNet Filter</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>MDD</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCMOPI260MN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:37:55.465Z</lastUpdated>
  </row>
</eudamedExport>