<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00198715635881</udiDi>
    <basicUdiDi>86001420031000139001CEYD</basicUdiDi>
    <tradeName>Ella</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cyvek, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000049483</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600-100-CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:54:52.316Z</lastUpdated>
  </row>
</eudamedExport>