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    <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>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000095-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:45:42.630Z</lastUpdated>
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    <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>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52-000027-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:45:37.819Z</lastUpdated>
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    <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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51-000025-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:45:36.238Z</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>Z12050280</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43-000954-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:45:35.428Z</lastUpdated>
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    <udiDi>05060110521791</udiDi>
    <basicUdiDi>506011052000Z7T5C01V003CR</basicUdiDi>
    <tradeName>LiDCO Injectate Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LiDCO Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000008036</manufacturerSrn>
    <authorisedRepresentativeName>LiDCO Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002681</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050785</emdnCode>
    <emdnDescription>INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM 50-EUW-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:27:31.091Z</lastUpdated>
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    <udiDi>05060110520800</udiDi>
    <basicUdiDi>506011052000Z7T5C01V005CV</basicUdiDi>
    <tradeName>Flow Regulator</tradeName>
    <deviceName>Flow Regulator</deviceName>
    <manufacturerName>LiDCO Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000008036</manufacturerSrn>
    <authorisedRepresentativeName>LiDCO Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002681</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050580</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM 33</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:27:14.273Z</lastUpdated>
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    <udiDi>05060110520107</udiDi>
    <basicUdiDi>506011052000Z7T1C01V000A7</basicUdiDi>
    <tradeName>LiDCO Sensor</tradeName>
    <deviceName>LiDCO Sensor</deviceName>
    <manufacturerName>LiDCO Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000008036</manufacturerSrn>
    <authorisedRepresentativeName>LiDCO Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002681</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050785</emdnCode>
    <emdnDescription>INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM 10 PAS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:27:11.874Z</lastUpdated>
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    <udiDi>04931921120491</udiDi>
    <basicUdiDi>4931921MD10015BJ</basicUdiDi>
    <tradeName>STANDARD ACCESSORY KIT A YD-121D</tradeName>
    <deviceName>Electrocardiograph, professional, multichannel</deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YD-121D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:23:01.181Z</lastUpdated>
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  <row>
    <udiDi>04897139610011</udiDi>
    <basicUdiDi>489713961001L4</basicUdiDi>
    <tradeName>Multichannel Electrocardiograph</tradeName>
    <deviceName>Multichannel Electrocardiograph</deviceName>
    <manufacturerName>PhysioSign Hong Kong Medical Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000041466</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHS-U10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:18:45.738Z</lastUpdated>
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  <row>
    <udiDi>04719873370122</udiDi>
    <basicUdiDi>471987337RootiRxDJ</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName>Rooti Rx System</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP01-50</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:51:21.845Z</lastUpdated>
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  <row>
    <udiDi>04719873370146</udiDi>
    <basicUdiDi>471987337RootiRxPatchTH8</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName>Rooti Rx Patch T</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP02-50</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:45:24.085Z</lastUpdated>
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    <udiDi>04719873370115</udiDi>
    <basicUdiDi>471987337RootiRxDJ</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName>Rooti Rx System</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:45:23.296Z</lastUpdated>
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  <row>
    <udiDi>04719872981756</udiDi>
    <basicUdiDi>471987298002QTERD001WH</basicUdiDi>
    <tradeName>PCA 300</tradeName>
    <deviceName>Portable ECG system (QT ECG)</deviceName>
    <manufacturerName>QT Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014384</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>QTERD100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:45:05.680Z</lastUpdated>
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  <row>
    <udiDi>04719872981084</udiDi>
    <basicUdiDi>471987298QTECGAPPQE</basicUdiDi>
    <tradeName>QT ECG APP</tradeName>
    <deviceName>QT ECG App</deviceName>
    <manufacturerName>QT Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014384</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050382</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Android</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:45:04.926Z</lastUpdated>
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    <udiDi>04719873370153</udiDi>
    <basicUdiDi>471987337RootiCare8E</basicUdiDi>
    <tradeName>Rooti</tradeName>
    <deviceName>RootiCare System</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050892</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RootiCare</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:46.883Z</lastUpdated>
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    <udiDi>04719873370139</udiDi>
    <basicUdiDi>471987337RootiRxPatchTH8</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName>Rooti Rx Patch T</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:45.310Z</lastUpdated>
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    <udiDi>04719873370092</udiDi>
    <basicUdiDi>471987337RootiRxDJ</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName>Rooti Rx System</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP02, RXAP03, RXMD01, RXMD02, ASCD01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:42.930Z</lastUpdated>
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    <udiDi>04719872981503</udiDi>
    <basicUdiDi>471987298002QTERD001WH</basicUdiDi>
    <tradeName>PCA 500</tradeName>
    <deviceName>Portable ECG system (QT ECG)</deviceName>
    <manufacturerName>QT Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014384</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>QTERD100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:10.003Z</lastUpdated>
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    <udiDi>04719872981060</udiDi>
    <basicUdiDi>471987298QTECGAPPQE</basicUdiDi>
    <tradeName>QT ECG APP</tradeName>
    <deviceName>QT ECG App</deviceName>
    <manufacturerName>QT Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014384</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050382</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>iOS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:07.599Z</lastUpdated>
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    <udiDi>04538612912252</udiDi>
    <basicUdiDi>4538612011009K</basicUdiDi>
    <tradeName>Sphygmomanometer and Sphygmograph Data Management System VSS-50</tradeName>
    <deviceName>Sphygmomanometer and Sphygmograph</deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSS-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:51:39.518Z</lastUpdated>
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