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    <deviceName></deviceName>
    <manufacturerName>Ivor Shaw Limited</manufacturerName>
    <manufacturerSrn>GB-PR-000023775</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME18001-PH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:32.654Z</lastUpdated>
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    <basicUdiDi>506043442LSCDH</basicUdiDi>
    <tradeName>05060434423962</tradeName>
    <deviceName>Quantum Reservoir Level Sensor Cradle Curved Taper (Box of 100)</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C030199</emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSC_HRF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:45:46.627Z</lastUpdated>
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    <udiDi>05060434422460</udiDi>
    <basicUdiDi>506043442QHCHK42</basicUdiDi>
    <tradeName>05060434422460</tradeName>
    <deviceName>Hose Kit - 12.5 mm Bore - 2.5 m long</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C030199</emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000044-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:45:40.215Z</lastUpdated>
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    <udiDi>05060912587780</udiDi>
    <basicUdiDi>50564696TPackoxRJ</basicUdiDi>
    <tradeName>Mini Prime tubing Set - Adult</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>MDR 2017/745</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME36002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:38:58.473Z</lastUpdated>
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    <udiDi>05060912585540</udiDi>
    <basicUdiDi>50564696TpackECoxG9</basicUdiDi>
    <tradeName>ECMO Tubing Pack with 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>MDR 2017/745</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CME90013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:38:57.673Z</lastUpdated>
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    <udiDi>05060912587858</udiDi>
    <basicUdiDi>50564696TPackECctox7B</basicUdiDi>
    <tradeName>Coated Adult ECMO Tubing Pack</tradeName>
    <deviceName>ECMO Coated Tubing Pack inc 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>MDR 2017/745</legislation>
    <emdnCode>C03010102</emdnCode>
    <emdnDescription>OXYGENATOR KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCME26002</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:38:56.112Z</lastUpdated>
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    <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>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CME95001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:38:52.875Z</lastUpdated>
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    <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>C03010301</emdnCode>
    <emdnDescription>CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CME90048</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:38:51.271Z</lastUpdated>
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    <udiDi>05060491616987</udiDi>
    <basicUdiDi>50564696TPackacNW</basicUdiDi>
    <tradeName>High Flow Pigtail</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>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>2026-07-31T05:28:45.658Z</lastUpdated>
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    <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>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>2026-07-31T05:28:44.951Z</lastUpdated>
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    <udiDi>04745011021618</udiDi>
    <basicUdiDi>47450110216EfferonLPS7K</basicUdiDi>
    <tradeName>Efferon® LPS</tradeName>
    <deviceName>Extracorporeal blood adsorber</deviceName>
    <manufacturerName>Efferon OÜ</manufacturerName>
    <manufacturerSrn>EE-MF-000024299</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>24LEU001</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:56:49.510Z</lastUpdated>
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    <udiDi>04260402640204</udiDi>
    <basicUdiDi>42604026424056</basicUdiDi>
    <tradeName>ECMO-Fix 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Novo Klinik-Service GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005289</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C030180</emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-300-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:57:41.272Z</lastUpdated>
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    <udiDi>04260090040560</udiDi>
    <basicUdiDi>4260090042533QN</basicUdiDi>
    <tradeName>04260090040560</tradeName>
    <deviceName>Driving tube</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L20H-002x01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:47.845Z</lastUpdated>
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    <udiDi>04260090040386</udiDi>
    <basicUdiDi>4260090042854RD</basicUdiDi>
    <tradeName>04260090040386</tradeName>
    <deviceName>Arterial cannula</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C85G-004m</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:43.832Z</lastUpdated>
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    <udiDi>04260090040379</udiDi>
    <basicUdiDi>4260090042878RT</basicUdiDi>
    <tradeName>04260090040379</tradeName>
    <deviceName>Atrial cannula</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C15V-040m</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:43.020Z</lastUpdated>
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    <udiDi>04260090040553</udiDi>
    <basicUdiDi>4260090040553QE</basicUdiDi>
    <tradeName>04260090040553</tradeName>
    <deviceName>Accessory set PU valves</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T00L-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:42.894Z</lastUpdated>
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    <udiDi>04260090040539</udiDi>
    <basicUdiDi>4260090042830QX</basicUdiDi>
    <tradeName>04260090040539</tradeName>
    <deviceName>Apex cannula</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C14A-040m</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:41.428Z</lastUpdated>
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    <udiDi>04260090040287</udiDi>
    <basicUdiDi>4260090042847RG</basicUdiDi>
    <tradeName>04260090040287</tradeName>
    <deviceName>Apex cannula</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C27A-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:24.600Z</lastUpdated>
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    <udiDi>04260090040232</udiDi>
    <basicUdiDi>4260090042885RQ</basicUdiDi>
    <tradeName>04260090040232</tradeName>
    <deviceName>Atrial cannula</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22V-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:23.770Z</lastUpdated>
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    <udiDi>04260090040201</udiDi>
    <basicUdiDi>4260090042908RB</basicUdiDi>
    <tradeName>04260090040201</tradeName>
    <deviceName>Graft-adapter cannula</deviceName>
    <manufacturerName>Berlin Heart GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C03010499</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION CANNULAS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C00P-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:30:22.967Z</lastUpdated>
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