BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CONCHA INC.

    Reg #: 3030627827 · FEI: 3030627827 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    CONCHA INC.
    Registration Number
    3030627827
    FEI Number
    3030627827
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    55 East 3rd Ave
    City
    San Mateo
    State
    CA
    ZIP
    94401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233747

    Owner / Operator

    Firm Name
    Concha Inc.
    Operator Number
    10090365
    Address
    55 East 3rd Ave
    City
    San Mateo
    State
    CA
    Postal Code
    94401
    Country
    US
    Correspondent
    Amy Li

    Products

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

    Proprietary Names

    Concha Sol Hearing Aids (CL-1001)

    Establishment Types

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