<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04170000225829</udiDi>
    <basicUdiDi>417000019368SC2168</basicUdiDi>
    <tradeName>Niviu</tradeName>
    <deviceName>Niviu System</deviceName>
    <manufacturerName>Elixion Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043056</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V030299</emdnCode>
    <emdnDescription>DIMENSIONAL CLINICAL PARAMETERS MEASURING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELX-0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:35:41.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>04170000225836</udiDi>
    <basicUdiDi>417000019368SC2168</basicUdiDi>
    <tradeName>Niviu</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixion Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043056</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V030299</emdnCode>
    <emdnDescription>DIMENSIONAL CLINICAL PARAMETERS MEASURING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELX-0002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:29:17.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>04170000249634</udiDi>
    <basicUdiDi>417000019368SC2168</basicUdiDi>
    <tradeName>Niviu System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elixion Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000043056</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V030299</emdnCode>
    <emdnDescription>DIMENSIONAL CLINICAL PARAMETERS MEASURING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELX-0010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:29:17.327Z</lastUpdated>
  </row>
</eudamedExport>