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    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX-1300M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.623Z</lastUpdated>
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    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
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    <reference>LX-1300N</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.593Z</lastUpdated>
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    <udiDi>04538612916397</udiDi>
    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX-1300E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.565Z</lastUpdated>
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    <udiDi>08032926007131</udiDi>
    <basicUdiDi>803292600RMMJ5</basicUdiDi>
    <tradeName>MEDICO</tradeName>
    <deviceName>ERMES_PLUS</deviceName>
    <manufacturerName>Medico Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000016800</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050899</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERMES_PLUS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:53:05.782Z</lastUpdated>
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    <udiDi>07290018223000</udiDi>
    <basicUdiDi>7290018223017WJ</basicUdiDi>
    <tradeName>CardiacSense Medical Watch</tradeName>
    <deviceName>CS System 4</deviceName>
    <manufacturerName>CardiacSense Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000014166</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-FG0015BK</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:22:42.331Z</lastUpdated>
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    <udiDi>06430081450052</udiDi>
    <basicUdiDi>643008145CSAFIB3Y</basicUdiDi>
    <tradeName>CardioSignal</tradeName>
    <deviceName>CardioSignal</deviceName>
    <manufacturerName>Precordior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000014540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050892</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iOS v. 3.1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:42.522Z</lastUpdated>
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    <udiDi>04260658320042</udiDi>
    <basicUdiDi>426065832HedyTMW4</basicUdiDi>
    <tradeName>Hedy Telemonitoring System</tradeName>
    <deviceName>Hedy Telemonitoring System</deviceName>
    <manufacturerName>Health Care Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020378</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:54:31.290Z</lastUpdated>
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    <udiDi>04260498565283</udiDi>
    <basicUdiDi>426049856DE55252NMTELWB</basicUdiDi>
    <tradeName>NR-314-T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR1207-D-00U-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:00:44.901Z</lastUpdated>
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    <udiDi>04538612061905</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>Silicone Cover for LX-1300</tradeName>
    <deviceName></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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050803</emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-1300C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.033Z</lastUpdated>
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    <udiDi>06430081450083</udiDi>
    <basicUdiDi>643008145CSAFIB3Y</basicUdiDi>
    <tradeName>CardioSignal Inside</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Precordior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000014540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050892</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Android v. 1.0</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:04:19.688Z</lastUpdated>
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    <udiDi>06430081450076</udiDi>
    <basicUdiDi>643008145CSAFIB3Y</basicUdiDi>
    <tradeName>CardioSignal Inside</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Precordior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000014540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050892</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iOS v. 1.0</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:04:18.464Z</lastUpdated>
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    <udiDi>06430081450069</udiDi>
    <basicUdiDi>643008145CSAFIB3Y</basicUdiDi>
    <tradeName>CardioSignal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Precordior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000014540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050892</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Android v. 3.1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:04:17.257Z</lastUpdated>
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    <udiDi>04260658320110</udiDi>
    <basicUdiDi>426065832HedyTMW4</basicUdiDi>
    <tradeName>Hedy Telemonitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Health Care Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020378</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:19.912Z</lastUpdated>
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    <udiDi>04260658320103</udiDi>
    <basicUdiDi>426065832HedyTMW4</basicUdiDi>
    <tradeName>Hedy Telemonitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Health Care Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020378</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:19.124Z</lastUpdated>
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    <udiDi>04260658320080</udiDi>
    <basicUdiDi>426065832HedyTMW4</basicUdiDi>
    <tradeName>Hedy Telemonitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Health Care Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020378</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:18.174Z</lastUpdated>
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    <udiDi>04260658320073</udiDi>
    <basicUdiDi>426065832HedyTMW4</basicUdiDi>
    <tradeName>Hedy Telemonitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Health Care Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020378</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:17.207Z</lastUpdated>
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    <udiDi>07290018223017</udiDi>
    <basicUdiDi>7290018223017WJ</basicUdiDi>
    <tradeName>CS System 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CardiacSense Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000014166</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-FG0015BK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:04:42.379Z</lastUpdated>
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