<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>18058480756183</udiDi>
    <basicUdiDi>803300326109000001P9</basicUdiDi>
    <tradeName>18058480756183</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F9019RDIN100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:37:00.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950099</udiDi>
    <basicUdiDi>4260334950099V4</basicUdiDi>
    <tradeName>CardioSecur Pace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00372</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:44:37.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903002217528</udiDi>
    <basicUdiDi>5903002221095N</basicUdiDi>
    <tradeName>Kabel EKG do badań holterowskich</tradeName>
    <deviceName>Holter ECG cables</deviceName>
    <manufacturerName>SORIMEX sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000020958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KH-2/0-Hb/2,2-HPs/L-35/60/35-205</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:55:31.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903002217511</udiDi>
    <basicUdiDi>5903002221095N</basicUdiDi>
    <tradeName>Kabel EKG do badań holterowskich</tradeName>
    <deviceName>Holter ECG cables</deviceName>
    <manufacturerName>SORIMEX sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000020958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KH-2/0-Hb/2,2-HPs/L-35/60/35-201</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:36:16.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903002217504</udiDi>
    <basicUdiDi>5903002221095N</basicUdiDi>
    <tradeName>Kabel EKG do badań holterowskich</tradeName>
    <deviceName>Holter ECG cables</deviceName>
    <manufacturerName>SORIMEX sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000020958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KH-2/0-Hb/2,2-HPs/L-35/60/60-204</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:26:59.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334953663</udiDi>
    <basicUdiDi>4260334953663W2</basicUdiDi>
    <tradeName>CardioSecur Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00368</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:24:06.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334951003</udiDi>
    <basicUdiDi>4260334951003U4</basicUdiDi>
    <tradeName>CardioSecur Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00153</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:24:05.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950501</udiDi>
    <basicUdiDi>4260334950501UJ</basicUdiDi>
    <tradeName>CardioSecur Active</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00154</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:24:04.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950082</udiDi>
    <basicUdiDi>4260334950082UK</basicUdiDi>
    <tradeName>CardioSecur Aviation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00403</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:24:01.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950075</udiDi>
    <basicUdiDi>4260334950075UN</basicUdiDi>
    <tradeName>CardioSecur Active</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:24:00.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950044</udiDi>
    <basicUdiDi>4260334950044UB</basicUdiDi>
    <tradeName>CardioSecur Active</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00407</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:23:59.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950020</udiDi>
    <basicUdiDi>4260334950020TV</basicUdiDi>
    <tradeName>CardioSecur Active</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00405</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:23:57.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950013</udiDi>
    <basicUdiDi>4260334950013TY</basicUdiDi>
    <tradeName>CardioSecur Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:23:54.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950006</udiDi>
    <basicUdiDi>4260334950006U3</basicUdiDi>
    <tradeName>CardioSecur Pace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Personal MedSystems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013935</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>A00306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:23:51.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-50002_a3A</udiDi>
    <basicUdiDi>B-50002_a3A</basicUdiDi>
    <tradeName>Cortrium Apex</tradeName>
    <deviceName>Cortrium Apex</deviceName>
    <manufacturerName>Cortrium ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000007827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50002_a</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:29.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040100478</udiDi>
    <basicUdiDi>B-06945040100478</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</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>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG300GT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:54:38.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040100072</udiDi>
    <basicUdiDi>B-06945040100072</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</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>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG100G</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:54:11.282Z</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>
</eudamedExport>