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<eudamedExport entity="devices">
  <row>
    <udiDi>06934666200167</udiDi>
    <basicUdiDi>B-06934666200167</basicUdiDi>
    <tradeName>ECG Event Recorder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BORSAM Biomedical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023994</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WeCardio WF</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:27.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934666200143</udiDi>
    <basicUdiDi>B-06934666200143</basicUdiDi>
    <tradeName>Holter ECG Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BORSAM Biomedical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023994</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS6940-12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:25.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934666200136</udiDi>
    <basicUdiDi>B-06934666200136</basicUdiDi>
    <tradeName>Holter ECG Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BORSAM Biomedical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023994</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS6940-3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:24.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934666200112</udiDi>
    <basicUdiDi>B-06934666200112</basicUdiDi>
    <tradeName>Holter ECG Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BORSAM Biomedical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023994</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS6930-12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:22.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934666200037</udiDi>
    <basicUdiDi>B-06934666200037</basicUdiDi>
    <tradeName>Holter ECG Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BORSAM Biomedical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023994</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iTengo</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:19.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934666200013</udiDi>
    <basicUdiDi>B-06934666200013</basicUdiDi>
    <tradeName>ECG Event Recorder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BORSAM Biomedical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023994</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WeCardio UN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:18.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934666200006</udiDi>
    <basicUdiDi>B-06934666200006</basicUdiDi>
    <tradeName>Holter ECG Workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BORSAM Biomedical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023994</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS6930-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:17.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103714</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>wellue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPatch-T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:31.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103707</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>wellue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPatch-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:30.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103684</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EHL-1D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:29.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103677</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>Checkme</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPatch-T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:28.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103660</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>Checkme</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPatch-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:25.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103356</udiDi>
    <basicUdiDi>69344401iHolter-12LM</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LeHolter-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:22.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103349</udiDi>
    <basicUdiDi>69344401iHolter-12LM</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LeHolter-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:19.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103332</udiDi>
    <basicUdiDi>69344401iHolter-12LM</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iHolter-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:18.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103325</udiDi>
    <basicUdiDi>69344401iHolter-12LM</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iHolter-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:17.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440103318</udiDi>
    <basicUdiDi>69344401iHolter-12LM</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XAB-M3AG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:35:16.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440102717</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>Checkme</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER1-LW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:34:40.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440102656</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER1-LB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:34:29.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934440102632</udiDi>
    <basicUdiDi>69344401ER1-LWER</basicUdiDi>
    <tradeName>LEPU MEDICAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Viatom Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012182</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER1-LB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:34:27.110Z</lastUpdated>
  </row>
</eudamedExport>