FDA.reportPublic FDA data

Unitron Hearing, a division of National Hearing Services Inc.

Matched from indexed company URL: UNITRON HEARING

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028084153002808415Unitron Hearing, a division of National Hearing Services Inc.1N2026-01-0120 BEASLEY DRIVE KITCHENER Ontario CA N2E 1Y6

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07613389075823UNITRON - Unitron Remote Plus app+1 519 895 0100quality@unitron.com
07613389221572UNITRON - TrueFit Fitting Software v3.7 USB USA+1 519 895 0100quality@unitron.com
07613389303285Unitron - TrueFit Fitting Software v4.x+1 519 895 0100quality@unitron.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3221761744450785K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidQUH2023-06-16
3221761648667977K123450PHONAK TINNITUS BALANCEKLW2013-02-11
3221761136003779
3221761421239643
3221761649591966

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QUH12023-06-16
KLW12013-02-11

PMN#

GUDID#

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