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<eudamedExport entity="devices">
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    <basicUdiDi>B-06948309089002</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>mTouch6</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:32:12.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309088944</udiDi>
    <basicUdiDi>B-06948309088944</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AcuitsignM3</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:31:01.879Z</lastUpdated>
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    <udiDi>06948309088869</udiDi>
    <basicUdiDi>B-06948309088869</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:31:00.473Z</lastUpdated>
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    <udiDi>06948309002650</udiDi>
    <basicUdiDi>B-06948309002650</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patinent monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AcuitsignM6</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:53.210Z</lastUpdated>
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  <row>
    <udiDi>06948309002643</udiDi>
    <basicUdiDi>B-06948309002643</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>mTouch8</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:52.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309002636</udiDi>
    <basicUdiDi>B-06948309002636</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S80</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:50.834Z</lastUpdated>
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  <row>
    <udiDi>06948309002629</udiDi>
    <basicUdiDi>B-06948309002629</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S90</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:49.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309002612</udiDi>
    <basicUdiDi>B-06948309002612</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patinent monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AcuitsignM5</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:43.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309002346</udiDi>
    <basicUdiDi>B-06948309002346</basicUdiDi>
    <tradeName>Handheld monitor</tradeName>
    <deviceName>Handhel monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM80</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:41.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309001387</udiDi>
    <basicUdiDi>B-06948309001387</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S90Express</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:40.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309001288</udiDi>
    <basicUdiDi>B-06948309001288</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S12</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:32.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309000069</udiDi>
    <basicUdiDi>B-06948309000069</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>h8</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:29.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948309000052</udiDi>
    <basicUdiDi>B-06948309000052</basicUdiDi>
    <tradeName>Patient monitor</tradeName>
    <deviceName>Patient monitor</deviceName>
    <manufacturerName>Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S60Vista</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:30:23.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413849174</udiDi>
    <basicUdiDi>69444138ES3STG</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:43:20.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413835214</udiDi>
    <basicUdiDi>69444138iT30SYS</basicUdiDi>
    <tradeName>Telemetry Monitor</tradeName>
    <deviceName>Telemetry Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iT50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:10.220Z</lastUpdated>
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    <udiDi>06944413835153</udiDi>
    <basicUdiDi>69444138iT30SYS</basicUdiDi>
    <tradeName>Telemetry Monitor</tradeName>
    <deviceName>Telemetry Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iT30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:36:06.618Z</lastUpdated>
  </row>
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    <udiDi>06944413813465</udiDi>
    <basicUdiDi>69444138iM3SS2J</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iHM3s</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:13:08.946Z</lastUpdated>
  </row>
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    <udiDi>06944413813458</udiDi>
    <basicUdiDi>69444138iM3SS2J</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iM3Bs</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:13:07.998Z</lastUpdated>
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    <udiDi>06944413813441</udiDi>
    <basicUdiDi>69444138iM3SS2J</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iM3As</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:13:06.546Z</lastUpdated>
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    <udiDi>06944413811171</udiDi>
    <basicUdiDi>69444138iM3SS2J</basicUdiDi>
    <tradeName>Vital Signs Monitor</tradeName>
    <deviceName>Vital Signs Monitor</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iM3s</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:09:39.954Z</lastUpdated>
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