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<eudamedExport entity="devices">
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    <udiDi>04250903202155</udiDi>
    <basicUdiDi>0425090320235N9</basicUdiDi>
    <tradeName>SEER 1000 Holter USB cable</tradeName>
    <deviceName>Download Cable</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2067634-021 / 85050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:34.848Z</lastUpdated>
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    <udiDi>04250903200250</udiDi>
    <basicUdiDi>0425090320234N7</basicUdiDi>
    <tradeName>CM 3000 GETEMED PRESS-STUD ADAPT-SET 7PC DIGI</tradeName>
    <deviceName>ECG-Cable</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2014606-039 / 90243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:34.053Z</lastUpdated>
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    <udiDi>04250903203046</udiDi>
    <basicUdiDi>0425090320276NP</basicUdiDi>
    <tradeName>HeartX Recorder Docking Station</tradeName>
    <deviceName>HeartX Recorder Docking Station</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86150 (Device without Packaging), 86151 (Device with GETEMED Packaging), 86151-IEM (Device with IEM Packaging)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:45.698Z</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>04250903202575</udiDi>
    <basicUdiDi>0425090320269NS</basicUdiDi>
    <tradeName>ReSTA</tradeName>
    <deviceName>ReSTA</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</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>75313011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:44.108Z</lastUpdated>
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    <udiDi>04250903202544</udiDi>
    <basicUdiDi>0425090320242N6</basicUdiDi>
    <tradeName>HeartX Management with inCareNet Dashboard</tradeName>
    <deviceName>HeartX Management with inCareNet Dashboard</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</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>79313031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:39.301Z</lastUpdated>
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    <udiDi>04250903202520</udiDi>
    <basicUdiDi>0425090320240N2</basicUdiDi>
    <tradeName>CardioDay</tradeName>
    <deviceName>CardioDay v2.x</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>Z12050492</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2092504-270</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:38.514Z</lastUpdated>
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  <row>
    <udiDi>04250903202513</udiDi>
    <basicUdiDi>0425090320243N8</basicUdiDi>
    <tradeName>PhysioMem PM 100 4G</tradeName>
    <deviceName>PhysioMem PM 100 4G</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>Z12050499</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77214001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:37.704Z</lastUpdated>
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  <row>
    <udiDi>04250903202483</udiDi>
    <basicUdiDi>0425090320241N4</basicUdiDi>
    <tradeName>HeartX Viewer</tradeName>
    <deviceName>HeartX Viewer</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>Z12050492</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79313011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:36.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250903200243</udiDi>
    <basicUdiDi>0425090320234N7</basicUdiDi>
    <tradeName>CM 3000 GETEMED PRESS-STUD ADAPT-SET 5PC DIGI</tradeName>
    <deviceName>ECG-Cable</deviceName>
    <manufacturerName>GETEMED Medizin- und Informationstechnik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000012384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2014606-038 / 90241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:32.093Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>00732094356311</udiDi>
    <basicUdiDi>0732094GMN901006DNN</basicUdiDi>
    <tradeName>H3+ Patient Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Welch Allyn, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013394</manufacturerSrn>
    <authorisedRepresentativeName>Welch Allyn Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000768</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050480</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9293-037-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T00:58:28.424Z</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>
  </row>
  <row>
    <udiDi>D-SYS03HLC05QQ</udiDi>
    <basicUdiDi>B-SYS03HLC05QQ</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>SYS-03HLC-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-23T16:57:26.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SYS02HLC05QB</udiDi>
    <basicUdiDi>B-SYS02HLC05QB</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>SYS-02HLC-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-23T16:57:25.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971438610441</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</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:05:12.839Z</lastUpdated>
  </row>
</eudamedExport>