<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06947437900111</udiDi>
    <basicUdiDi>69474379DCARLeadwireJF</basicUdiDi>
    <tradeName>ECG Leadwires and Trunk Cables</tradeName>
    <deviceName>ECG Leadwires and trunk cables</deviceName>
    <manufacturerName>Shenzhen Launch Electrical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028780</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2104727-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:12:27.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020786</udiDi>
    <basicUdiDi>69454290EL001KA</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:11:22.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936735460441</udiDi>
    <basicUdiDi>69456648DEC1VD</basicUdiDi>
    <tradeName>Disposable ECG  Lead Wire</tradeName>
    <deviceName>Disposable ECG Lead Wires</deviceName>
    <manufacturerName>Unimed Medical Supplies, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001480</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDM5-310DS-I</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:07:05.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936735460052</udiDi>
    <basicUdiDi>69456648REA1Y9</basicUdiDi>
    <tradeName>Limb Clamp Electrode</tradeName>
    <deviceName>EKG accessories</deviceName>
    <manufacturerName>Unimed Medical Supplies, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001480</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UU-LC-AA</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:07:04.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936735437078</udiDi>
    <basicUdiDi>69456648REC1YF</basicUdiDi>
    <tradeName>ECG Monitor Lead Wire</tradeName>
    <deviceName>ECG Cables &amp; Lead Wires</deviceName>
    <manufacturerName>Unimed Medical Supplies, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001480</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQB5-90/120P-I</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:07:04.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040104421</udiDi>
    <basicUdiDi>69450401PM10NX</basicUdiDi>
    <tradeName>Portable ECG Monitor</tradeName>
    <deviceName>Portable ECG Monitor</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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:03:33.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040103455</udiDi>
    <basicUdiDi>69450401CONTEC8000GA5</basicUdiDi>
    <tradeName>ECG Workstation</tradeName>
    <deviceName>ECG Workstation</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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONTEC8000G</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:03:27.426Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>06945040100089</udiDi>
    <basicUdiDi>69450401ECG1212G5V</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG300G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:02:27.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904040189</udiDi>
    <basicUdiDi>69449040AB010000563R</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BeneHeart R3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:53:35.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053074919</udiDi>
    <basicUdiDi>69449040AB010000573T</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BeneHeart R70</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:25.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430035221035</udiDi>
    <basicUdiDi>643003522PatientCableF5</basicUdiDi>
    <tradeName>IEC 2-electrode 1-CH patient cable 125 mm</tradeName>
    <deviceName>Patient Cables</deviceName>
    <manufacturerName>Bittium Biosignals Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000013983</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>S0000022709</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:51:35.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430035221011</udiDi>
    <basicUdiDi>643003522SuiteMYW</basicUdiDi>
    <tradeName>Bittium MedicalSuite Mobile</tradeName>
    <deviceName>MedicalSuite Mobile</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>Z12050482</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9530433</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:51:34.231Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>06429810883025</udiDi>
    <basicUdiDi>64298108830026M</basicUdiDi>
    <tradeName>Movesense Chest Strap MD - Size S</tradeName>
    <deviceName>Movesense Chest Strap MD</deviceName>
    <manufacturerName>Movesense Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000024281</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>MS2</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:45:35.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06261388700799</udiDi>
    <basicUdiDi>62613887JamH1WM</basicUdiDi>
    <tradeName>SAADAT</tradeName>
    <deviceName>Cardiac telemetery system</deviceName>
    <manufacturerName>Pooyandegan rah saadat</manufacturerName>
    <manufacturerSrn>IR-MF-000007104</manufacturerSrn>
    <authorisedRepresentativeName>Trionara Technologies AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000005045</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>57109489</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:55.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06261388700560</udiDi>
    <basicUdiDi>62613887JamS3XS</basicUdiDi>
    <tradeName>SAADAT</tradeName>
    <deviceName>Cardiac telemetery system</deviceName>
    <manufacturerName>Pooyandegan rah saadat</manufacturerName>
    <manufacturerSrn>IR-MF-000007104</manufacturerSrn>
    <authorisedRepresentativeName>Trionara Technologies AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000005045</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050801</emdnCode>
    <emdnDescription>COMPLETE CARDIAC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26411662</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:43.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06261388700539</udiDi>
    <basicUdiDi>62613887Dena1210MP</basicUdiDi>
    <tradeName>SAADAT</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Pooyandegan rah saadat</manufacturerName>
    <manufacturerSrn>IR-MF-000007104</manufacturerSrn>
    <authorisedRepresentativeName>Trionara Technologies AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000005045</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99113285</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:42.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06261388700379</udiDi>
    <basicUdiDi>62613887Dena650BL</basicUdiDi>
    <tradeName>SAADAT</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Pooyandegan rah saadat</manufacturerName>
    <manufacturerSrn>IR-MF-000007104</manufacturerSrn>
    <authorisedRepresentativeName>Trionara Technologies AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000005045</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70085480</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:38.278Z</lastUpdated>
  </row>
  <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>
</eudamedExport>