BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    WS Audiology Mexico S.A. de C.V.

    Reg #: 3019918054 · FEI: 3019918054 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    31
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    WS Audiology Mexico S.A. de C.V.
    Registration Number
    3019918054
    FEI Number
    3019918054
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calle Todos Los Santos #9201, Col. Parque Industrial Pacifico II
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K220403

    Owner / Operator

    Firm Name
    WS Audiology USA, Inc.
    Operator Number
    9050836
    Address
    101 Wood Avenue South, 7th Floor
    City
    Iselin
    State
    NJ
    Postal Code
    08830
    Country
    US
    Correspondent
    Isabel - Restivo

    US Agent

    Business Name
    WS Audiology USA, Inc.
    Contact Name
    Isabel Restivo
    Address
    101 Wood Ave S Ste 7
    City
    Iselin
    State
    NJ
    ZIP
    08830
    Country
    US
    Email
    [email protected]
    Phone
    551 5799581

    Products

    Device Name Product Code
    Audiometer EWO
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Hearing Aid, Air-Conduction, Prescription ESD

    Proprietary Names

    SHOEBOX Consult SHOEBOX PureTest Pure 312 AX CONNEXX Intuis 4 Motion Charge&Go Signia Pure Rexton CROS Signia Intuis Signia Silk Signia Active IX Signia IX Rexton M-Core Signia Styletto Rexton Reach Signia Active Pure Charge&Go Signia Intuis 3 Signia Insio Silk Charge&Go Signia Active Pro ALLURE Styletto IX Signia Motion Rexton Styletto AX Evoke Moment Magnify Enjoy

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device