BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose

    Reg #: 3014337591 · FEI: 3014337591 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HEARX SA
    Registration Number
    3014337591
    FEI Number
    3014337591
    Status
    Active
    Expiry Year
    2025
    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
    K211008

    Owner / Operator

    Firm Name
    hearX Group
    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
    Seline van der Wat

    US Agent

    Business Name
    FDAbasics LLC
    Contact Name
    Jerry Doane
    Address
    15815 Sw 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

    Proprietary Names

    Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Lexie B2 Plus Self-fitting OTC Hearing Aids, Powered by Bose Lexie B1 Self-fitting OTC Hearing Aids, Powered by Bose

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198