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    <basicUdiDi>69444138SE2003SFG</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>SE-2012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:00.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413800960</udiDi>
    <basicUdiDi>69444138SE2003SFG</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>SE-2003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:45:59.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942103163166</udiDi>
    <basicUdiDi>694210319442319H6</basicUdiDi>
    <tradeName>HUAWEI WATCH D2</tradeName>
    <deviceName>Wrist Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>Huawei Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022811</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55020FKE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:15:02.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942103131417</udiDi>
    <basicUdiDi>694210319442319H6</basicUdiDi>
    <tradeName>HUAWEI WATCH D2</tradeName>
    <deviceName>Wrist Ambulatory Blood Pressure Monitor</deviceName>
    <manufacturerName>Huawei Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022811</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050404</emdnCode>
    <emdnDescription>BLOOD PRESSURE HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LCA-B10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T07:15:00.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299735316</udiDi>
    <basicUdiDi>87202997353SenseLinkDC</basicUdiDi>
    <tradeName>08720299735316</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeMeCo B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011503</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SLE-3IEC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:03.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299735323</udiDi>
    <basicUdiDi>87202997353SenseLinkDC</basicUdiDi>
    <tradeName>08720299735323</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeMeCo B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011503</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SLE-5IEC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:02.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299735330</udiDi>
    <basicUdiDi>87202997353SenseLinkDC</basicUdiDi>
    <tradeName>08720299735330</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeMeCo B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011503</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SLE-12IEC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:02.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299735354</udiDi>
    <basicUdiDi>87202997353SenseLinkDC</basicUdiDi>
    <tradeName>08720299735354</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeMeCo B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011503</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SLEM-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:02.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299735361</udiDi>
    <basicUdiDi>87202997353SenseLinkDC</basicUdiDi>
    <tradeName>08720299735361</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeMeCo B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011503</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SLOM-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:02.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299735378</udiDi>
    <basicUdiDi>87202997353SenseLinkDC</basicUdiDi>
    <tradeName>SenseLink</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeMeCo B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011503</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>SL01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:02.925Z</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>06934666200228</udiDi>
    <basicUdiDi>B-06934666200228</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 TTM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:31.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934666200174</udiDi>
    <basicUdiDi>B-06934666200174</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>Holter Patch</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:53:29.124Z</lastUpdated>
  </row>
  <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>
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  <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>
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