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    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIP-03C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:51.184Z</lastUpdated>
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    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIP-03B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:48.774Z</lastUpdated>
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    <udiDi>06970912081180</udiDi>
    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</deviceName>
    <manufacturerName>Biomedical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIP-03A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:45.167Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BI9900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:22.346Z</lastUpdated>
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    <udiDi>06970912080831</udiDi>
    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BI9100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:19.958Z</lastUpdated>
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    <udiDi>06970912080824</udiDi>
    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSC 6612</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:16.337Z</lastUpdated>
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    <udiDi>06970912080817</udiDi>
    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP830-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:13.937Z</lastUpdated>
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    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP830</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:12.748Z</lastUpdated>
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    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP820-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:10.340Z</lastUpdated>
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    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:06.735Z</lastUpdated>
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    <basicUdiDi>697091208AECGGJ</basicUdiDi>
    <tradeName>Holter System</tradeName>
    <deviceName>Holter System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRAK-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:30:04.345Z</lastUpdated>
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