<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06937683471527</udiDi>
    <basicUdiDi>69376834iHBB5</basicUdiDi>
    <tradeName>Ambulatory Blood Pressure Recorders and Associated Software</tradeName>
    <deviceName>Ambulatory Blood Pressure Recorders and Associated Software</deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90310911</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:14:48.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683471114</udiDi>
    <basicUdiDi>69376834iHLQ</basicUdiDi>
    <tradeName>Ambulatory Electrocardiographs</tradeName>
    <deviceName>Ambulatory Electrocardiographs</deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90310181-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:14:47.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683471213</udiDi>
    <basicUdiDi>69376834iHLQ</basicUdiDi>
    <tradeName>Ambulatory Electrocardiographs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90310184-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:45.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683443128</udiDi>
    <basicUdiDi>B-06937683443128</basicUdiDi>
    <tradeName>Doppler Fetal Heart Rate Detector</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90210106</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:43.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683441148</udiDi>
    <basicUdiDi>B-06937683441148</basicUdiDi>
    <tradeName>Fetal Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90210108</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:41.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683441124</udiDi>
    <basicUdiDi>B-06937683441124</basicUdiDi>
    <tradeName>Fetal Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90210104</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:39.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683428163</udiDi>
    <basicUdiDi>B-06937683428163</basicUdiDi>
    <tradeName>Central Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030201</emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90720101</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:38.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683428156</udiDi>
    <basicUdiDi>B-06937683428156</basicUdiDi>
    <tradeName>Patient Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90300121-01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:37.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683427166</udiDi>
    <basicUdiDi>B-06937683427166</basicUdiDi>
    <tradeName>Patient Monito</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90300110-01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:35.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683426374</udiDi>
    <basicUdiDi>B-06937683426374</basicUdiDi>
    <tradeName>Fingertip Pulse Oximeter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90300146</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:33.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683424127</udiDi>
    <basicUdiDi>B-06937683424127</basicUdiDi>
    <tradeName>Patient Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90300132</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:32.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683415125</udiDi>
    <basicUdiDi>B-06937683415125</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90120122</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:31.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683414319</udiDi>
    <basicUdiDi>B-06937683414319</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90160103</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:30.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683413855</udiDi>
    <basicUdiDi>B-06937683413855</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90120136-01</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:27.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683413329</udiDi>
    <basicUdiDi>B-06937683413329</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90120168</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:26.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683413022</udiDi>
    <basicUdiDi>B-06937683413022</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90120170</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:25.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683412377</udiDi>
    <basicUdiDi>B-06937683412377</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90130148-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:24.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683412346</udiDi>
    <basicUdiDi>B-06937683412346</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90130135</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:21.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683411530</udiDi>
    <basicUdiDi>B-06937683411530</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90120176</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:20.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937683411448</udiDi>
    <basicUdiDi>B-06937683411448</basicUdiDi>
    <tradeName>Digital Electrocardiograph</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biocare Bio-Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005653</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90110144</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:19.557Z</lastUpdated>
  </row>
</eudamedExport>