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<eudamedExport entity="devices">
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    <udiDi>06945040100294</udiDi>
    <basicUdiDi>69450401TLC6000GX</basicUdiDi>
    <tradeName>Dynamic ECG Systems</tradeName>
    <deviceName>Dynamic ECG Systems</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLC5000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:02:57.843Z</lastUpdated>
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    <udiDi>06430035220885</udiDi>
    <basicUdiDi>643003522Cardiac3Z</basicUdiDi>
    <tradeName>Mini UL</tradeName>
    <deviceName>Bittium MINI UL</deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</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>S0000018246</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:51:30.220Z</lastUpdated>
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    <udiDi>05999883490006</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-2H Recorder</tradeName>
    <deviceName>EC-2H System</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</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>EC-2H Recorder</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:06.908Z</lastUpdated>
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    <udiDi>05905471789018</udiDi>
    <basicUdiDi>590547178901002QB</basicUdiDi>
    <tradeName>CardioWaver</tradeName>
    <deviceName>Rejestrator holterowski EKG</deviceName>
    <manufacturerName>SynexCare sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000038028</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>1002100000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:06:49.366Z</lastUpdated>
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  <row>
    <udiDi>05745000379002</udiDi>
    <basicUdiDi>5745000379HolterMonitorVN</basicUdiDi>
    <tradeName>C3+ Holter Monitor</tradeName>
    <deviceName>C3+ Holter Monitor</deviceName>
    <manufacturerName>Cortrium ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000007827</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>50002</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:39:55.091Z</lastUpdated>
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    <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>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>04260585221818</udiDi>
    <basicUdiDi>426058522ECG-RecorderB8</basicUdiDi>
    <tradeName>VIREOFLEX3</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>107158</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:28:11.800Z</lastUpdated>
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    <udiDi>04260585220781</udiDi>
    <basicUdiDi>426058522ECG-RecorderB8</basicUdiDi>
    <tradeName>kECG-3</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>106877</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:21:10.602Z</lastUpdated>
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    <udiDi>04260585220644</udiDi>
    <basicUdiDi>426058522ECG-RecorderB8</basicUdiDi>
    <tradeName>kECG-3 (Kardiobeat.ai)</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>106895</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:11:52.025Z</lastUpdated>
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    <udiDi>04260498565061</udiDi>
    <basicUdiDi>426049856DE55252NMAMBTG</basicUdiDi>
    <tradeName>NR-302</tradeName>
    <deviceName>NR Series</deviceName>
    <manufacturerName>Norav Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006715</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>NR302-D-00E-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:02:51.344Z</lastUpdated>
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    <udiDi>00817980020191</udiDi>
    <basicUdiDi>0817980021303YC</basicUdiDi>
    <tradeName>Ambulatory Electrocardiograph</tradeName>
    <deviceName>Vasomedical-Biox™  1303 Ultra Compact 3 Channel ECG Holter Recorder</deviceName>
    <manufacturerName>Vasomedical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030121</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.13.03.0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:00:24.723Z</lastUpdated>
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    <udiDi>00817980020184</udiDi>
    <basicUdiDi>0817980021306YJ</basicUdiDi>
    <tradeName>00817980020184</tradeName>
    <deviceName>Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder</deviceName>
    <manufacturerName>Vasomedical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030121</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.13.06.0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:00:23.117Z</lastUpdated>
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    <udiDi>04250903203039</udiDi>
    <basicUdiDi>0425090320274NK</basicUdiDi>
    <tradeName>HeartX</tradeName>
    <deviceName>HeartX Recorder</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</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>86100; 86100-IEM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:44.893Z</lastUpdated>
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    <udiDi>B146EP2520</udiDi>
    <basicUdiDi>B-B146EP2520</basicUdiDi>
    <tradeName>ePatch 2.5 ECG Recorder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Braemar Manufacturing, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000036101</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-02046</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:08:19.263Z</lastUpdated>
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    <udiDi>B146EP2020</udiDi>
    <basicUdiDi>B-B146EP2020</basicUdiDi>
    <tradeName>ePatch 2.0 Sensor</tradeName>
    <deviceName>ePatch 2.0 ECG Recorder</deviceName>
    <manufacturerName>Braemar Manufacturing, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000036101</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>02-01650</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:08:18.486Z</lastUpdated>
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  <row>
    <udiDi>D-SET12HLC05B3</udiDi>
    <basicUdiDi>B-SET12HLC05B3</basicUdiDi>
    <tradeName>EC-12H</tradeName>
    <deviceName>EC-12H 12-channel ECG Holter</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET-12HLC-05 B</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:00:13.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SET03HLC05AX</udiDi>
    <basicUdiDi>B-SET03HLC05AX</basicUdiDi>
    <tradeName>EC-3H</tradeName>
    <deviceName>EC-3H 3-channel ECG Holter</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET-03HLC-05 B</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:00:12.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SET02HLC05AJ</udiDi>
    <basicUdiDi>B-SET02HLC05AJ</basicUdiDi>
    <tradeName>EC-2H</tradeName>
    <deviceName>EC-2H 2-channel ECG Holter</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET-02HLC-05 B</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:00:11.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SYS12HLC05QU</udiDi>
    <basicUdiDi>B-SYS12HLC05QU</basicUdiDi>
    <tradeName>EC-12H</tradeName>
    <deviceName>EC-12H 12-channel ECG Holter</deviceName>
    <manufacturerName>LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.</manufacturerName>
    <manufacturerSrn>HU-MF-000002846</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-12HLC-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-23T16:57:27.278Z</lastUpdated>
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</eudamedExport>