<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974297655059</udiDi>
    <basicUdiDi>B-06974297655059</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Guangzhou 3RAY Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ECG-5515B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:40.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974297655042</udiDi>
    <basicUdiDi>B-06974297655042</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Guangzhou 3RAY Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG-5512G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:39.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974297655035</udiDi>
    <basicUdiDi>B-06974297655035</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Guangzhou 3RAY Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG-5512B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:38.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974297655028</udiDi>
    <basicUdiDi>B-06974297655028</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Guangzhou 3RAY Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG-5503G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:35.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974297655011</udiDi>
    <basicUdiDi>B-06974297655011</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Guangzhou 3RAY Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG-5503B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:42:34.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973660370018</udiDi>
    <basicUdiDi>B-06973660370018</basicUdiDi>
    <tradeName>Mintti</tradeName>
    <deviceName>Dynamic ECG Monitor</deviceName>
    <manufacturerName>Suzhou Melodicare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021493</manufacturerSrn>
    <authorisedRepresentativeName>Share Info Consultant Service LLC Repräsentanzbüro</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005133</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT-H1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:31:23.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820967358</udiDi>
    <basicUdiDi>B-06972820967358</basicUdiDi>
    <tradeName>SB0523</tradeName>
    <deviceName>IBP Cable</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:55.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820963985</udiDi>
    <basicUdiDi>B-06972820963985</basicUdiDi>
    <tradeName>SG522DR-W</tradeName>
    <deviceName>ECG</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:54.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820963978</udiDi>
    <basicUdiDi>B-06972820963978</basicUdiDi>
    <tradeName>SG522DR-B</tradeName>
    <deviceName>ECG</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:53.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820963961</udiDi>
    <basicUdiDi>B-06972820963961</basicUdiDi>
    <tradeName>SG522DR-Y</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:52.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820963954</udiDi>
    <basicUdiDi>B-06972820963954</basicUdiDi>
    <tradeName>SG522DR-G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:47.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820963947</udiDi>
    <basicUdiDi>B-06972820963947</basicUdiDi>
    <tradeName>SG522DR-R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:47.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820963930</udiDi>
    <basicUdiDi>B-06972820963930</basicUdiDi>
    <tradeName>Patient Cable and Leadwires</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-00-00</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:46.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972820963480</udiDi>
    <basicUdiDi>B-06972820963480</basicUdiDi>
    <tradeName>IBP Cable</tradeName>
    <deviceName>IBP Cable</deviceName>
    <manufacturerName>Shenzhen SINO-K Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021157</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-10-00</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:41.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971049341796</udiDi>
    <basicUdiDi>B-06971049341796</basicUdiDi>
    <tradeName>06971049341796</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Carewell EIectronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026800</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NeoECG T180</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:07:47.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971049341628</udiDi>
    <basicUdiDi>B-06971049341628</basicUdiDi>
    <tradeName>06971049341628</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Carewell EIectronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026800</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LeECG OT12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:07:47.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971049341987</udiDi>
    <basicUdiDi>B-06971049341987</basicUdiDi>
    <tradeName>06971049341987</tradeName>
    <deviceName>AI-ECG Tracker</deviceName>
    <manufacturerName>Shenzhen Carewell EIectronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026800</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:07:44.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971049341611</udiDi>
    <basicUdiDi>B-06971049341611</basicUdiDi>
    <tradeName>06971049341611</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Carewell EIectronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026800</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LeECG OS12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:07:27.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971049341604</udiDi>
    <basicUdiDi>B-06971049341604</basicUdiDi>
    <tradeName>06971049341604</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Carewell EIectronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026800</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NeoECG T180</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:07:26.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971049341574</udiDi>
    <basicUdiDi>B-06971049341574</basicUdiDi>
    <tradeName>06971049341574</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Shenzhen Carewell EIectronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026800</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NeoECG S120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:07:25.721Z</lastUpdated>
  </row>
</eudamedExport>