<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05999883490242</udiDi>
    <basicUdiDi>5999883490ECGSRY</basicUdiDi>
    <tradeName>EC-12R V6</tradeName>
    <deviceName>EC-12S V6</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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-12R V6</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:07.698Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <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>05999883490525</udiDi>
    <basicUdiDi>B-05999883490525</basicUdiDi>
    <tradeName>EC-ABP</tradeName>
    <deviceName>EC-ABP Long Term Ambulatory Blood Pressure Monitor</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>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-00ABP-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:53.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490235</udiDi>
    <basicUdiDi>B-05999883490235</basicUdiDi>
    <tradeName>EC-12RM</tradeName>
    <deviceName>EC-12RM 12-channel mobile and emergency ECG</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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-012RM-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:53.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490228</udiDi>
    <basicUdiDi>B-05999883490228</basicUdiDi>
    <tradeName>EC-12S</tradeName>
    <deviceName>EC-12S 12-channel Stress ECG with Blood Pressure Monitor</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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-0012S-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:52.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490211</udiDi>
    <basicUdiDi>B-05999883490211</basicUdiDi>
    <tradeName>EC-12R/S</tradeName>
    <deviceName>EC-12R/S PC-based 12-channel resting and stress ECG</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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-012RS-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:51.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490204</udiDi>
    <basicUdiDi>B-05999883490204</basicUdiDi>
    <tradeName>EC-12R</tradeName>
    <deviceName>EC-12R PC-based 12-channel Resting ECG</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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS-0012R-05</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:47.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490037</udiDi>
    <basicUdiDi>B-05999883490037</basicUdiDi>
    <tradeName>EC-3H/ABP</tradeName>
    <deviceName>EC-3H/ABP 3-channel ECG Holter and Ambulatory Blood Pressure Monitor</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>Z12050402</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET-3H/ABP-05 B</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:46.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490020</udiDi>
    <basicUdiDi>B-05999883490020</basicUdiDi>
    <tradeName>EC-ABP</tradeName>
    <deviceName>EC-ABP Long Term Ambulatory Blood Pressure Monitor</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>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET-00ABP-05 B</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:11:45.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490013</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-3H Recorder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-3H Recorder</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490044</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-12H Recorder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-12H Recorder</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490051</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-ABP V6 Recorder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-ABP V6 Recorder</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490068</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-3H/ABP V6 Recorder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-3H/ABP V6 Recorder</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883490075</udiDi>
    <basicUdiDi>5999883490HOLTERSR9</basicUdiDi>
    <tradeName>EC-12H/ABP V6 Recorder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-12H/ABP V6 Recorder</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.873Z</lastUpdated>
  </row>
</eudamedExport>