<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08806712906225</udiDi>
    <basicUdiDi>8806712POCBGCT00123</basicUdiDi>
    <tradeName>i-Smart 300 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT001-300T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:16.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906232</udiDi>
    <basicUdiDi>8806712POCBGCT00123</basicUdiDi>
    <tradeName>i-Smart 300 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT001-300T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:16.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906256</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-100T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906263</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-200T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906270</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-200T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906287</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-300T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906300</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-50T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:09.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906317</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-100T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:07.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906324</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-100T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:04.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906331</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-200T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:03.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906348</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-200T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:03.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906355</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-300T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:02.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906362</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-300T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:02.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976083811540</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06976083811540</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060699</emdnCode>
    <emdnDescription>BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT10-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:18:21.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976083811533</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06976083811533</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060699</emdnCode>
    <emdnDescription>BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT9G-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:18:15.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976083811526</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06976083811526</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060699</emdnCode>
    <emdnDescription>BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT9L-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:18:14.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976083811519</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06976083811519</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060699</emdnCode>
    <emdnDescription>BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT8-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:18:13.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976083811502</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06976083811502</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060699</emdnCode>
    <emdnDescription>BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT6-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:18:11.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976083811496</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06976083811496</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060699</emdnCode>
    <emdnDescription>BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT6E-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:18:05.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976083811489</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06976083811489</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060699</emdnCode>
    <emdnDescription>BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT5-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:18:04.606Z</lastUpdated>
  </row>
</eudamedExport>