FDA.reportPublic FDA data

Widex Eesti OU

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108755543010875554Widex Eesti OU1N2020-04-25Saeveski Str. 10A Tallinn Harjumaa EE 11214

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1709081114449454K110973IE-ZEN (IN CLEAR SERIES HEARING AID)KLW2011-05-05
1709081739522338K080955ZEN PROGRAM (MIND 440 HEARING AID)KLW2008-06-27
1709081028726786DEN100025WIDEXLINK IN CLEAR SERIES HEARING AIDSOSM2011-03-31
1709081352221836

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KLW22011-05-05
OSM12011-03-31