<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00860008017956</udiDi>
    <basicUdiDi>8600080179FenomDW</basicUdiDi>
    <tradeName>Fenom Pro</tradeName>
    <deviceName>Fenom Pro Mouthpiece</deviceName>
    <manufacturerName>CAIRE Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030745</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9001</emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-0019-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:01:38.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008017925</udiDi>
    <basicUdiDi>8600080179FenomPro,EUVU</basicUdiDi>
    <tradeName>Fenom Pro</tradeName>
    <deviceName>Fractional Exhaled Nitric Oxide Breath Analyzer</deviceName>
    <manufacturerName>CAIRE Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030745</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079099</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-0007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:01:37.758Z</lastUpdated>
  </row>
</eudamedExport>