<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08806712906294</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName>CarePak 110 Cartridge</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>POCBGCT005-50T2W</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:07.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906140</udiDi>
    <basicUdiDi>8806712POCBGCT00123</basicUdiDi>
    <tradeName>i-Smart 300 Cartridge</tradeName>
    <deviceName>i-Smart 300 Cartridge</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>POCBGCT001-30T2W</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:05.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906249</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 Cartridge</tradeName>
    <deviceName>CarePak 108 Cartridge</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>POCBGCT004-50T3W</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:05.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906058</udiDi>
    <basicUdiDi>8806712POCECT003GX</basicUdiDi>
    <tradeName>i-Smart 30 PRO Cartridge</tradeName>
    <deviceName>i-Smart 30 PRO Cartridge</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCECT003-50T4W</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:03.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906102</udiDi>
    <basicUdiDi>8806712POCECT004GZ</basicUdiDi>
    <tradeName>i-Smart 30 PRO Cartridge E4</tradeName>
    <deviceName>i-Smart 30 PRO Cartridge E4</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCECT004-50T4W</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:01.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712905976</udiDi>
    <basicUdiDi>8806712POCECT002GV</basicUdiDi>
    <tradeName>i-Smart 30 Cartridge E5</tradeName>
    <deviceName>i-Smart 30 Cartridge E5</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCECT002-50T2W</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:47.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712905907</udiDi>
    <basicUdiDi>8806712POCECT001GT</basicUdiDi>
    <tradeName>i-Smart 30 Cartridge</tradeName>
    <deviceName>i-Smart 30 Cartridge</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCECT001-50T2W</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:45.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712905723</udiDi>
    <basicUdiDi>8806712POCEQC001HW</basicUdiDi>
    <tradeName>i-Smart Electrolyte Quality Control</tradeName>
    <deviceName>i-Smart Electrolyte Quality Control</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCEQC001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:43.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712901152</udiDi>
    <basicUdiDi>8806712POCBGAL002XL</basicUdiDi>
    <tradeName>i-SmartCare 10 Blood Gas Analyzer</tradeName>
    <deviceName>i-SmartCare 10 Blood Gas Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGAL002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:42.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712901091</udiDi>
    <basicUdiDi>8806712POCBGAL001XJ</basicUdiDi>
    <tradeName>i-Smart 300 Blood Gas Analyzer</tradeName>
    <deviceName>i-Smart 300 Blood Gas Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGAL001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:41.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712900926</udiDi>
    <basicUdiDi>8806712POCEAL002EF</basicUdiDi>
    <tradeName>i-Smart 30 PRO Electrolyte Analyzer</tradeName>
    <deviceName>i-Smart 30 PRO Electrolyte Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCEAL002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:38.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712900896</udiDi>
    <basicUdiDi>8806712POCEAL001ED</basicUdiDi>
    <tradeName>i-Smart 30 Electrolyte Analyzer</tradeName>
    <deviceName>i-Smart 30 Electrolyte Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCEAL001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:36.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712010274</udiDi>
    <basicUdiDi>8806712CGMR001T5</basicUdiDi>
    <tradeName>CareSens Air Receiver</tradeName>
    <deviceName>Receiver</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011599</emdnCode>
    <emdnDescription>BLOOD SUGAR MONITORING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGM-R-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:35.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712009902</udiDi>
    <basicUdiDi>8806712POCSPAL001CB</basicUdiDi>
    <tradeName>A1Care Analyzer</tradeName>
    <deviceName>A1Care Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCSPAL001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:33.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712005980</udiDi>
    <basicUdiDi>8806712CGM001PS</basicUdiDi>
    <tradeName>CareSens Air Continuous Glucose Monitoring System</tradeName>
    <deviceName>Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011501</emdnCode>
    <emdnDescription>NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGM-ST-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:31.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712005096</udiDi>
    <basicUdiDi>8806712CGMUA001Y4</basicUdiDi>
    <tradeName>CareSens Air app</tradeName>
    <deviceName>Continuous Glucose Monitoring System App</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011599</emdnCode>
    <emdnDescription>BLOOD SUGAR MONITORING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS-MA-11, HS-WA-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:29.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712004518</udiDi>
    <basicUdiDi>8806712CGMDM001UV</basicUdiDi>
    <tradeName>Sens365</tradeName>
    <deviceName>Glucose Data Management Software</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1204011599</emdnCode>
    <emdnDescription>BLOOD SUGAR MONITORING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS-MI-01, HS-WI-11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:29.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260413710231</udiDi>
    <basicUdiDi>8806712LC001SF</basicUdiDi>
    <tradeName>alphacheck professional Lancing Device</tradeName>
    <deviceName>Lancing Device</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:42:37.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906157</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>POCBGCT001-30T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:25.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806712906164</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>POCBGCT001-50T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:24.833Z</lastUpdated>
  </row>
</eudamedExport>