<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00860005178810</udiDi>
    <basicUdiDi>B-00860005178810</basicUdiDi>
    <tradeName>Spatz3 Adjustable Balloon System</tradeName>
    <deviceName>Spatz3 Adjustable Balloon System Insertion Kit</deviceName>
    <manufacturerName>Spatz FGIA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012214</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030601</emdnCode>
    <emdnDescription>INTRAGASTRIC BALLOON SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-SP3-03K</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:54.830Z</lastUpdated>
  </row>
</eudamedExport>