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    <deviceName>Vital Signs™ Diagnostic Cardiology Leadwire Adapter</deviceName>
    <manufacturerName>AirLife Finland Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001482</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <reference>30344421</reference>
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    <lastUpdated>2026-07-15T19:59:22.143Z</lastUpdated>
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    <tradeName>Vital Signs™ Leadwire A1 for KISS™ System</tradeName>
    <deviceName>Vital Signs™  ECG leadwires for KISS system</deviceName>
    <manufacturerName>AirLife Finland Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001482</manufacturerSrn>
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    <lastUpdated>2026-07-15T19:59:16.530Z</lastUpdated>
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    <deviceName>ECG app</deviceName>
    <manufacturerName>Apple Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013709</manufacturerSrn>
    <authorisedRepresentativeName>Apple Distribution International Limited</authorisedRepresentativeName>
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    <deviceName>ECG app</deviceName>
    <manufacturerName>Apple Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013709</manufacturerSrn>
    <authorisedRepresentativeName>Apple Distribution International Limited</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG app 1.X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:43:02.149Z</lastUpdated>
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    <udiDi>G419CPLT10</udiDi>
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    <tradeName>CardioPad Lite</tradeName>
    <deviceName>CardioPad Lite</deviceName>
    <manufacturerName>Aizoi s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000026605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPL-T1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:04:28.123Z</lastUpdated>
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    <udiDi>+G243ECG000DHR200</udiDi>
    <basicUdiDi>++G243DHEARTECG4L</basicUdiDi>
    <tradeName>D-Heart</tradeName>
    <deviceName>D-Heart Portable ECG Device</deviceName>
    <manufacturerName>Strena Medical Srl Società Benefit</manufacturerName>
    <manufacturerSrn>IT-MF-000021080</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG000-DHR20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:21:44.033Z</lastUpdated>
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    <tradeName>CER-S</tradeName>
    <deviceName>CER-S</deviceName>
    <manufacturerName>CARDIO CALM S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000017950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050482</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCZ1205048205</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T14:23:20.887Z</lastUpdated>
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    <basicUdiDi>++B972TELECC32W</basicUdiDi>
    <tradeName>TELECARDIOCALM</tradeName>
    <deviceName>TELECARDIOCALM</deviceName>
    <manufacturerName>CARDIO CALM S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000033759</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC0102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T14:18:43.289Z</lastUpdated>
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    <tradeName>Kardia 12L</tradeName>
    <deviceName>Kardia 12L</deviceName>
    <manufacturerName>AliveCor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029146</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050302</emdnCode>
    <emdnDescription>ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-027</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:53:37.783Z</lastUpdated>
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    <udiDi>B2100020190</udiDi>
    <basicUdiDi>++B210KS12LS7</basicUdiDi>
    <tradeName>KardiaStation 12L (iOS)</tradeName>
    <deviceName>KardiaStation 12L App</deviceName>
    <manufacturerName>AliveCor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029146</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002019</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:53:36.924Z</lastUpdated>
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    <udiDi>B141MEDISQFRXA20240</udiDi>
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    <tradeName>QFR</tradeName>
    <deviceName>Medis QFR XA</deviceName>
    <manufacturerName>Medis Medical Imaging Systems bv</manufacturerName>
    <manufacturerSrn>NL-MF-000002670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050582</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Medis QFR XA 2024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:52:30.919Z</lastUpdated>
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    <udiDi>B141MEDISQFRXA20220</udiDi>
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    <tradeName>QFR</tradeName>
    <deviceName>Medis QFR XA</deviceName>
    <manufacturerName>Medis Medical Imaging Systems bv</manufacturerName>
    <manufacturerSrn>NL-MF-000002670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050582</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Medis QFR XA 2022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:52:30.888Z</lastUpdated>
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    <udiDi>B108076POFF12MEU00</udiDi>
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    <tradeName>BTL Flexi 12 ECG</tradeName>
    <deviceName>BTL Flexi 12 ECG</deviceName>
    <manufacturerName>BTL Industries Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034894</manufacturerSrn>
    <authorisedRepresentativeName>BTL ITALIA S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000020508</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C076.014; C076.013; C076.004; C076.003</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:43.799Z</lastUpdated>
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    <udiDi>B009OCSLungConsoleGY</udiDi>
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    <tradeName>B009OCSLungConsoleGY</tradeName>
    <deviceName>OCS Lung Console</deviceName>
    <manufacturerName>TransMedics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000029912</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050201</emdnCode>
    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:28.860Z</lastUpdated>
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    <udiDi>B009OCSLungAccessoryJF</udiDi>
    <basicUdiDi>++B009OCSLungAccessoryJF</basicUdiDi>
    <tradeName>B009OCSLungAccessoryJF</tradeName>
    <deviceName>OCS Lung Instrumentation Tool Set</deviceName>
    <manufacturerName>TransMedics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000029912</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2401, 2402, 2403, 2404</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:26.862Z</lastUpdated>
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    <udiDi>B009OCSHeartConsole2E</udiDi>
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    <tradeName>B009OCSHeartConsole2E</tradeName>
    <deviceName>OCS Heart Console</deviceName>
    <manufacturerName>TransMedics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000029912</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnDescription>EXTRA-CORPOREAL CIRCULATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100004929</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:16.264Z</lastUpdated>
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    <udiDi>B009OCSCommonClass2aGF</udiDi>
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    <tradeName>B009OCSCommonClass2aGF</tradeName>
    <deviceName>OCS Class IIa Accessories/Components</deviceName>
    <manufacturerName>TransMedics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000029912</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100004460</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:50:14.669Z</lastUpdated>
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    <tradeName>Medis QFR XA</tradeName>
    <deviceName>Medis QFR XA</deviceName>
    <manufacturerName>Medis Medical Imaging Systems bv</manufacturerName>
    <manufacturerSrn>NL-MF-000002670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEDISQFRXA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:47:08.280Z</lastUpdated>
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    <manufacturerName>iSEKS diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016478</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.P.30.00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:52.934Z</lastUpdated>
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    <deviceName>Wearable Ambulatory ECG Recorder</deviceName>
    <manufacturerName>Shenzhen Benevolence Medical Sci&amp;Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021136</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:08.965Z</lastUpdated>
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