BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    HEARX SA

    Reg #: 3014337591 · FEI: 3014337591 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    15
    Establishment Types
    4
    Classifications
    6

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    Registration Details

    Registration Name
    HEARX SA
    Registration Number
    3014337591
    FEI Number
    3014337591
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road, Ashlea Gardens
    City
    Pretoria Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K223137

    Owner / Operator

    Firm Name
    hearX
    Operator Number
    10057906
    Address
    Ground Floor, Building 2, Ashlea Gardens Office Park,, 180 Garsfontein Road, Ashlea Gardens
    City
    Pretoria
    State
    Gauteng
    Postal Code
    0081
    Country
    ZA
    Correspondent
    Jade Blanchard

    US Agent

    Business Name
    FDAbasics
    Contact Name
    Emily Matorin
    Address
    1 Prospect Park W Apt 4d
    City
    Brooklyn
    State
    NY
    ZIP
    11215
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Audiometer EWO
    Otoscope ERA
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Hearing Aid, Air-Conduction, Over The Counter QUF

    Proprietary Names

    Lexie B3 Hearing Aids Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application hearOAE hearTest OccHealth hearScreen USA hearTest STK hearScreen hearScope Lexie H1 OTC Hearing Buds Go Ultra OTC Hearing Aids Lexie B2 Plus Self-fitting OTC Hearing Aids, Powered by Bose Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Lexie B1 Self-fitting OTC Hearing Aids, Powered by Bose Go Prime OTC Hearing Aids

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198