<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06956913490077</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:54.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490084</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:54.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490091</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:47.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490107</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:46.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490114</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:46.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490121</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:46.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490138</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:45.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490145</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:45.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490152</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:45.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490169</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:44.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956913490176</udiDi>
    <basicUdiDi>695691348214MQ</basicUdiDi>
    <tradeName>ZONCARE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan Zoncare Bio-medical Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010439</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>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:44.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260334950068</udiDi>
    <basicUdiDi>4260334950068UR</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>A00406</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:33:59.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672114173</udiDi>
    <basicUdiDi>4015672114175A</basicUdiDi>
    <tradeName>04015672114173</tradeName>
    <deviceName>HCG-8011B (HCG-8011B-E)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-8011B-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:36.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672114098</udiDi>
    <basicUdiDi>4015672114095B</basicUdiDi>
    <tradeName>04015672114098</tradeName>
    <deviceName>HCG-8060T (HCG-8060T-E)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-8060T-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:26.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770036057008</udiDi>
    <basicUdiDi>3770036057NOMIX4R</basicUdiDi>
    <tradeName>NOMIX</tradeName>
    <deviceName>NOMIX</deviceName>
    <manufacturerName>MESURONS</manufacturerName>
    <manufacturerSrn>FR-MF-000043601</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>NOMIX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:59.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>01976443006932</udiDi>
    <basicUdiDi>197644300693HW10TH</basicUdiDi>
    <tradeName>01976443006932</tradeName>
    <deviceName>VitalScan ANS (HW10)</deviceName>
    <manufacturerName>Medeia Group Ltd</manufacturerName>
    <manufacturerSrn>BG-MF-000025710</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>VitalScan ANS (HW10)</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:06:10.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970010882184</udiDi>
    <basicUdiDi>697001088ECG-32506Q</basicUdiDi>
    <tradeName>06970010882184</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000013567</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T18:15:32.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970010881675</udiDi>
    <basicUdiDi>697001088ECG-33506V</basicUdiDi>
    <tradeName>06970010881675</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000013567</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T18:15:09.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970010881569</udiDi>
    <basicUdiDi>697001088ECG-31506K</basicUdiDi>
    <tradeName>06970010881569</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>CN-MF-000013567</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T18:14:53.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278276087</udiDi>
    <basicUdiDi>8406821BUG00244HA</basicUdiDi>
    <tradeName>MAC 5 Lite Resting ECG Analysis System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8855003-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T14:39:49.634Z</lastUpdated>
  </row>
</eudamedExport>