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<eudamedExport entity="devices">
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    <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>171600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.918Z</lastUpdated>
  </row>
  <row>
    <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>
    <riskClass>Sınıf IIa</riskClass>
    <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>
  </row>
  <row>
    <udiDi>04057155000634</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>171610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000641</udiDi>
    <basicUdiDi>4057155Z12150101001C3</basicUdiDi>
    <tradeName>MasterScope WSSU / MasterScope 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>171611</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000665</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>151311, 151314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000672</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>151312, 151315</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000689</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>151261</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000696</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>151262</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000719</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>707405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000726</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>151310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000757</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>151220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000764</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>151260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000771</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>707406</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000788</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>151313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000801</udiDi>
    <basicUdiDi>4057155Z12150101004C9</basicUdiDi>
    <tradeName>SpiroWay</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>892114</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000825</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>707407</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:08.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>04057155000948</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>2026-06-22T08:15:08.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904726809037</udiDi>
    <basicUdiDi>5904726809klips4K</basicUdiDi>
    <tradeName>Jednorazowe kształtki z pianki</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pulmeq sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000029225</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PQKN-03</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:16:10.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904726809020</udiDi>
    <basicUdiDi>5904726809klips4K</basicUdiDi>
    <tradeName>Klips na nos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pulmeq sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000029225</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PQKN-02</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:16:08.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904726809006</udiDi>
    <basicUdiDi>B-05904726809006</basicUdiDi>
    <tradeName>Jednorazowy filtr do badań spirometrycznych</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pulmeq sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000029225</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PQFS-30S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:16:06.510Z</lastUpdated>
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</eudamedExport>