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<eudamedExport entity="devices">
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    <udiDi>05060434424662</udiDi>
    <basicUdiDi>50604344263-000001-00V8</basicUdiDi>
    <tradeName>05060434424662</tradeName>
    <deviceName>Quantum Informatics - Vision / Live Vue</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>Z12030201</emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISION/LIVE VUE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:17:06.747Z</lastUpdated>
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  <row>
    <udiDi>05060434424648</udiDi>
    <basicUdiDi>50604344260-000022-00T8</basicUdiDi>
    <tradeName>05060434424648</tradeName>
    <deviceName>Quantum Informatics - Viper</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIPER</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:17:02.747Z</lastUpdated>
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  <row>
    <udiDi>05060434424617</udiDi>
    <basicUdiDi>506043442QLTEP</basicUdiDi>
    <tradeName>05060434424617</tradeName>
    <deviceName>Quantum Light - SAP1</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></emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000140-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:17:01.949Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51-000160-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:17:01.189Z</lastUpdated>
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  <row>
    <udiDi>05060434423962</udiDi>
    <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></emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSC_HRF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:17:00.328Z</lastUpdated>
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    <udiDi>05060434423832</udiDi>
    <basicUdiDi>506043442IRMAK4D</basicUdiDi>
    <tradeName>05060434423832</tradeName>
    <deviceName>IRMA Adaptor Kit</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></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000096-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:16:59.538Z</lastUpdated>
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    <udiDi>05060434423818</udiDi>
    <basicUdiDi>506043442GSLDA</basicUdiDi>
    <tradeName>05060434423818</tradeName>
    <deviceName>Gas Sample Line 0.2 m</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></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000095-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:16:58.730Z</lastUpdated>
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    <udiDi>05060434422699</udiDi>
    <basicUdiDi>506043442QPSL95</basicUdiDi>
    <tradeName>05060434422699</tradeName>
    <deviceName>Quantum Power Supply Lite (QPSL)</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></emdnCode>
    <emdnDescription>CARDIOCIRCULATORY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51-000126-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:16:57.943Z</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></emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000044-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:16:57.132Z</lastUpdated>
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  <row>
    <udiDi>05060434422132</udiDi>
    <basicUdiDi>506043442QCDHC2L</basicUdiDi>
    <tradeName>05060434422132</tradeName>
    <deviceName>Quantum Centrifugal Emergency Hand Crank High Pressure</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></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000027-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:16:56.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060434422040</udiDi>
    <basicUdiDi>506043442QPFE7</basicUdiDi>
    <tradeName>05060434422040</tradeName>
    <deviceName>Quantum Pump Frame 2 (v2) - Cheltenham (QPF2)</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></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51-000025-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:16:55.596Z</lastUpdated>
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    <udiDi>05060434420992</udiDi>
    <basicUdiDi>506043442QRPHC7R</basicUdiDi>
    <tradeName>05060434420992</tradeName>
    <deviceName>Hand Crank Assembly - 4 inch</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></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43-000954-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:16:54.732Z</lastUpdated>
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    <udiDi>05060434421005</udiDi>
    <basicUdiDi>506043442QRPHC7R</basicUdiDi>
    <tradeName>05060434421005</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43-000955-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.275Z</lastUpdated>
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    <udiDi>05060434421012</udiDi>
    <basicUdiDi>506043442QRPHC7R</basicUdiDi>
    <tradeName>05060434421012</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43-000956-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.262Z</lastUpdated>
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    <udiDi>05060434422149</udiDi>
    <basicUdiDi>506043442QCDHC2L</basicUdiDi>
    <tradeName>05060434422149</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000028-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.220Z</lastUpdated>
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    <udiDi>05060434422453</udiDi>
    <basicUdiDi>506043442QPFE7</basicUdiDi>
    <tradeName>05060434422453</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QPF4 - part no. 51-000059-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.207Z</lastUpdated>
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    <udiDi>05060434422477</udiDi>
    <basicUdiDi>506043442QHCHK42</basicUdiDi>
    <tradeName>05060434422477</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000045-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.166Z</lastUpdated>
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    <udiDi>05060434422484</udiDi>
    <basicUdiDi>506043442QHCHK42</basicUdiDi>
    <tradeName>05060434422484</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000046-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.143Z</lastUpdated>
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    <udiDi>05060434422491</udiDi>
    <basicUdiDi>506043442QHCHK42</basicUdiDi>
    <tradeName>05060434422491</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000047-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.125Z</lastUpdated>
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    <udiDi>05060434422514</udiDi>
    <basicUdiDi>506043442QPFE7</basicUdiDi>
    <tradeName>05060434422514</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QPF7 - part no. 51-000099-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.105Z</lastUpdated>
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