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    <deviceName>Spirometer systems</deviceName>
    <manufacturerName>Suzhou Beneware Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015853</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-02-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T02:11:57.988Z</lastUpdated>
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    <udiDi>06958066408077</udiDi>
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    <tradeName>Spirometer</tradeName>
    <deviceName>Spirometer systems</deviceName>
    <manufacturerName>Suzhou Beneware Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015853</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
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    <lastUpdated>2026-06-29T02:11:56.922Z</lastUpdated>
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    <udiDi>04057155000030</udiDi>
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    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-22T08:15:09.333Z</lastUpdated>
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    <tradeName>MasterScope ECG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.313Z</lastUpdated>
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    <udiDi>04057155000061</udiDi>
    <basicUdiDi>4057155Z12150101001C3</basicUdiDi>
    <tradeName>MasterScope CT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>706235</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.293Z</lastUpdated>
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    <udiDi>04057155000078</udiDi>
    <basicUdiDi>4057155Z12150101001C3</basicUdiDi>
    <tradeName>Pneumotach</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>709554</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.273Z</lastUpdated>
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    <udiDi>04057155000368</udiDi>
    <basicUdiDi>4057155Z12150101001C3</basicUdiDi>
    <tradeName>Pneumotach</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>709555</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.176Z</lastUpdated>
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    <udiDi>04057155000375</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>SpiroSphere Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>707410, 151210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.152Z</lastUpdated>
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    <udiDi>04057155000412</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>ERT PT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>706000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.121Z</lastUpdated>
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    <udiDi>04057155000528</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>SpiroSphere</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.093Z</lastUpdated>
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    <udiDi>04057155000535</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>SpiroSphere</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.067Z</lastUpdated>
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    <udiDi>04057155000542</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>SpiroSphere</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.037Z</lastUpdated>
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    <udiDi>04057155000566</udiDi>
    <basicUdiDi>4057155Z12150101001C3</basicUdiDi>
    <tradeName>MasterScope WSSU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>707419</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:09.015Z</lastUpdated>
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  <row>
    <udiDi>04057155000580</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>SpiroSphere ECG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.995Z</lastUpdated>
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  <row>
    <udiDi>04057155000597</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>CardioSphere</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151222</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.974Z</lastUpdated>
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    <udiDi>04057155000610</udiDi>
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    <tradeName>MasterScope CT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.918Z</lastUpdated>
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    <udiDi>04057155000627</udiDi>
    <basicUdiDi>4057155Z12150101001C3</basicUdiDi>
    <tradeName>MasterScope CT / MasterScope ECG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.892Z</lastUpdated>
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    <udiDi>04057155000634</udiDi>
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    <tradeName>MasterScope WSSU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.866Z</lastUpdated>
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    <udiDi>04057155000641</udiDi>
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    <tradeName>MasterScope WSSU / MasterScope ECG</tradeName>
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    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171611</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.842Z</lastUpdated>
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    <udiDi>04057155000665</udiDi>
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    <tradeName>SpiroSphere ECG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151311, 151314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.782Z</lastUpdated>
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