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<eudamedExport entity="devices">
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    <udiDi>06970912081319</udiDi>
    <basicUdiDi>697091208PS2G</basicUdiDi>
    <tradeName>Wearable ECG Sensor</tradeName>
    <deviceName>Wearable ECG Sensor</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-B3E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:31:01.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081302</udiDi>
    <basicUdiDi>697091208PS2G</basicUdiDi>
    <tradeName>Wearable ECG Sensor</tradeName>
    <deviceName>Wearable ECG Sensor</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-B3D</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:31:00.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081111</udiDi>
    <basicUdiDi>697091208PS2G</basicUdiDi>
    <tradeName>Wearable ECG Sensor</tradeName>
    <deviceName>Wearable ECG Sensor</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-B3C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:42.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081104</udiDi>
    <basicUdiDi>697091208PS2G</basicUdiDi>
    <tradeName>Wearable ECG Sensor</tradeName>
    <deviceName>Wearable ECG Sensor</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-B3B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:41.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081098</udiDi>
    <basicUdiDi>697091208PS2G</basicUdiDi>
    <tradeName>Wearable ECG Sensor</tradeName>
    <deviceName>Wearable ECG Sensor</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:39.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081081</udiDi>
    <basicUdiDi>697091208PL22</basicUdiDi>
    <tradeName>ECG Patient Cable</tradeName>
    <deviceName>ECG Patient Cable</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL-M3B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:35.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081074</udiDi>
    <basicUdiDi>697091208PL22</basicUdiDi>
    <tradeName>ECG Patient Cable</tradeName>
    <deviceName>ECG Patient Cable</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL-M3A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:33.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081067</udiDi>
    <basicUdiDi>697091208PL22</basicUdiDi>
    <tradeName>ECG Patient Cable</tradeName>
    <deviceName>ECG Patient Cable</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL-B3B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:31.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081050</udiDi>
    <basicUdiDi>697091208PL22</basicUdiDi>
    <tradeName>ECG Patient Cable</tradeName>
    <deviceName>ECG Patient Cable</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL-B3A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:29.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081043</udiDi>
    <basicUdiDi>697091208PL22</basicUdiDi>
    <tradeName>ECG Patient Cable</tradeName>
    <deviceName>ECG Patient Cable</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL-U3B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:25.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970912081036</udiDi>
    <basicUdiDi>697091208PL22</basicUdiDi>
    <tradeName>ECG Patient Cable</tradeName>
    <deviceName>ECG Patient Cable</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL-U3A, PL-U3B, PL-B3A, PL-B3B, PL-M3A, PL-M3B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:23.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522130755</udiDi>
    <basicUdiDi>08415221IEMPATCHOWNBU</basicUdiDi>
    <tradeName>Eclipse Mini</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T02:36:19.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522128714</udiDi>
    <basicUdiDi>08415221IEPROC&amp;POWN7U</basicUdiDi>
    <tradeName>ECLIPSE PRO,CABLE,PX,3 SNAP,SHORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522129674</udiDi>
    <basicUdiDi>08415221IEPROC&amp;POWN7U</basicUdiDi>
    <tradeName>ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,LONG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522129698</udiDi>
    <basicUdiDi>08415221IEPROC&amp;POWN7U</basicUdiDi>
    <tradeName>ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,SHORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841522129728</udiDi>
    <basicUdiDi>08415221IEPROC&amp;POWN7U</basicUdiDi>
    <tradeName>ECLIPSE PRO,DEFIB CABLE,PX,4 SNAP,SHORT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spacelabs Healthcare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000001196</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050485</emdnCode>
    <emdnDescription>HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:27:06.640Z</lastUpdated>
  </row>
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