<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03661540304088</udiDi>
    <basicUdiDi>B-03661540304088</basicUdiDi>
    <tradeName>03661540304088</tradeName>
    <deviceName>ChloroChek® Chloridometer® Sweat Chloride Analyzer</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040203</emdnCode>
    <emdnDescription>CHLORIDE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Model 3400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:54.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699226000196</udiDi>
    <basicUdiDi>86992260UCF2011TW</basicUdiDi>
    <tradeName>CFΔ  Collection System</tradeName>
    <deviceName>SWEAT CHLORIDE ANALYZER / TERDE KLOR ANALİZÖRÜ</deviceName>
    <manufacturerName>UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000016643</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040203</emdnCode>
    <emdnDescription>CHLORIDE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UCF2011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:09:12.821Z</lastUpdated>
  </row>
</eudamedExport>