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<eudamedExport entity="devices">
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    <udiDi>07090052220023</udiDi>
    <basicUdiDi>709005222ECG247SENSORZ2</basicUdiDi>
    <tradeName>ECG247</tradeName>
    <deviceName>ECG247 Sensor</deviceName>
    <manufacturerName>Appsens AS</manufacturerName>
    <manufacturerSrn>NO-MF-000013438</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:15:35.474Z</lastUpdated>
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  <row>
    <udiDi>06976389830108</udiDi>
    <basicUdiDi>697638983E00UV</basicUdiDi>
    <tradeName>ECG Recorder</tradeName>
    <deviceName>ECG  Recorde</deviceName>
    <manufacturerName>Qingdao Weheal Technology co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000039585</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>None</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:07:31.406Z</lastUpdated>
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  <row>
    <udiDi>06976389830023</udiDi>
    <basicUdiDi>697638983Y00XZ</basicUdiDi>
    <tradeName>ECG Recorder</tradeName>
    <deviceName>ECG Recorder</deviceName>
    <manufacturerName>Qingdao Weheal Technology co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000039585</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>None</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:07:27.426Z</lastUpdated>
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    <udiDi>06973075231201</udiDi>
    <basicUdiDi>697307523HolterPocketSC</basicUdiDi>
    <tradeName>06973075231201</tradeName>
    <deviceName>Holter Pocket</deviceName>
    <manufacturerName>Wenzhou Shengkai Technology Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021411</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:34:52.115Z</lastUpdated>
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  <row>
    <udiDi>06971438610014</udiDi>
    <basicUdiDi>697143861000001PA</basicUdiDi>
    <tradeName>Wearable DECG Recorder</tradeName>
    <deviceName>Wearable DECG Recorder</deviceName>
    <manufacturerName>THOTH (Suzhou) Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034906</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>TER011、TER012、EP-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:57:29.621Z</lastUpdated>
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  <row>
    <udiDi>06971438610007</udiDi>
    <basicUdiDi>697143861000004PG</basicUdiDi>
    <tradeName>Wearable ECG Sensor</tradeName>
    <deviceName>Wearable ECG Sensor</deviceName>
    <manufacturerName>THOTH (Suzhou) Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034906</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LES-1、LES-2、LES-3、LES-X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:57:28.820Z</lastUpdated>
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    <udiDi>06937683471527</udiDi>
    <basicUdiDi>69376834iHBB5</basicUdiDi>
    <tradeName>Ambulatory Blood Pressure Recorders and Associated Software</tradeName>
    <deviceName>Ambulatory Blood Pressure Recorders and Associated Software</deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90310911</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:14:48.299Z</lastUpdated>
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  <row>
    <udiDi>06937683471114</udiDi>
    <basicUdiDi>69376834iHLQ</basicUdiDi>
    <tradeName>Ambulatory Electrocardiographs</tradeName>
    <deviceName>Ambulatory Electrocardiographs</deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90310181-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:14:47.498Z</lastUpdated>
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  <row>
    <udiDi>06934440102670</udiDi>
    <basicUdiDi>69344401iHolter-12LM</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName>Dynamic ECG Recorder</deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XAB-M12AL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:58:42.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440101963</udiDi>
    <basicUdiDi>69344401M12WA</basicUdiDi>
    <tradeName>LEPU</tradeName>
    <deviceName>Wireless Dynamic Multi-parameter Holter</deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050402</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:58:37.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440101918</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>Wellue</tradeName>
    <deviceName>Dynamic ECG Recorder</deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER1-LW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:58:18.591Z</lastUpdated>
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    <udiDi>05905331580137</udiDi>
    <basicUdiDi>590533158HOLTER.1185V</basicUdiDi>
    <tradeName>Comarch Holter</tradeName>
    <deviceName>Comarch Holter</deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050492</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580137</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:09:05.815Z</lastUpdated>
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    <udiDi>05905331580038</udiDi>
    <basicUdiDi>590533158ECGVIEW2.12L5</basicUdiDi>
    <tradeName>Comarch ECGViewer 2.0</tradeName>
    <deviceName>Comarch ECGViewer 2.0</deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050492</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580038</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:09:04.214Z</lastUpdated>
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    <udiDi>05905331580021</udiDi>
    <basicUdiDi>590533158CVVIEWER2.129X</basicUdiDi>
    <tradeName>Comarch CardioViewer</tradeName>
    <deviceName>Comarch CardioViewer</deviceName>
    <manufacturerName>Comarch Telemedicine Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000049884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050492</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05905331580021</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:09:03.413Z</lastUpdated>
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    <udiDi>05903021560247</udiDi>
    <basicUdiDi>590302156PECGT-IVMG</basicUdiDi>
    <tradeName>PocketECG IV</tradeName>
    <deviceName>Unified Arrhythmia Diagnostic System PocketECG IV</deviceName>
    <manufacturerName>Medicalgorithmics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000011413</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05903021560247</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:30:08.265Z</lastUpdated>
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    <udiDi>04260585220668</udiDi>
    <basicUdiDi>426058522ECG-RecorderB8</basicUdiDi>
    <tradeName>dpv-ritmo III</tradeName>
    <deviceName>ECG Holter Recorder</deviceName>
    <manufacturerName>livetec Ingenieurbüro GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005598</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106881</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:49:03.224Z</lastUpdated>
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    <udiDi>04250403710228</udiDi>
    <basicUdiDi>42504037AAG118000-01BY</basicUdiDi>
    <tradeName>PADSY Holter 4.6</tradeName>
    <deviceName>PADSY Holter</deviceName>
    <manufacturerName>Medset Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000016442</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050492</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AAG118102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:30:38.418Z</lastUpdated>
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    <udiDi>37700248000124</udiDi>
    <basicUdiDi>3770024800SASoftwareX9</basicUdiDi>
    <tradeName>Somno-Art Software</tradeName>
    <deviceName>Somno-Art Software</deviceName>
    <manufacturerName>PPRS</manufacturerName>
    <manufacturerSrn>FR-MF-000013227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050492</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3770024800SASoftwareX9</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:40.298Z</lastUpdated>
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    <udiDi>03700814300309</udiDi>
    <basicUdiDi>37008143BRA0001WV</basicUdiDi>
    <tradeName>Brassard Diasys 3+ Standard (avec microphone)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NOVACOR</manufacturerName>
    <manufacturerSrn>FR-MF-000017735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC-0210-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:32:23.268Z</lastUpdated>
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    <udiDi>03700814300125</udiDi>
    <basicUdiDi>37008143CAB0001QU</basicUdiDi>
    <tradeName>Câble ECG 5 brins Standard Gris (CHB)</tradeName>
    <deviceName>Accessories Cables</deviceName>
    <manufacturerName>NOVACOR</manufacturerName>
    <manufacturerSrn>FR-MF-000017735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC-0103-04</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:32:22.457Z</lastUpdated>
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