BEUDAMED
    FDA Registration Active 🇨🇳 China

    Eargo SE

    Reg #: 3006011998 · FEI: 3006011998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MAINTEK COMPUTER (SUZHOU) CO.,LTD.
    Registration Number
    3006011998
    FEI Number
    3006011998
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 233, Jinfeng Road
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221698

    Owner / Operator

    Firm Name
    Pegatron Corporation
    Operator Number
    10079441
    Address
    No. 76, Ligong St., Beitou District,
    City
    Taipei
    State
    TW-NOTA
    Postal Code
    112
    Country
    TW
    Correspondent
    Stella Chiang

    Products

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

    Proprietary Names

    Eargo SE Eargo 5 Eargo 6 Eargo 8 Eargo 7

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)