BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Bigbreathe BreST Mask

    Reg #: 3015972815 · FEI: 3015972815 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GH INNOTEK CO., LTD.
    Registration Number
    3015972815
    FEI Number
    3015972815
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, Room B2, 68, Busandaehak-ro 50beon-gil
    City
    Geumjeong-gu Busan
    Country
    KR

    Owner / Operator

    Firm Name
    GH Innotek Co., Ltd.
    Operator Number
    10084379
    Address
    2F, Room B2, 68, Busandaehak-ro 50beon-gil,
    City
    Geumjeong-gu
    State
    Busan
    Postal Code
    46285
    Country
    KR

    US Agent

    Business Name
    J.S. CHEM INTERNATIONAL CO.
    Contact Name
    Grace Kim
    Address
    20155 Pingree Way
    City
    Yorba Linda
    State
    CA
    ZIP
    92887
    Country
    US
    Email
    [email protected]
    Phone
    310 5983012

    Products

    Device Name Product Code
    Exerciser, Non-Measuring ION

    Proprietary Names

    Bigbreathe BreST Mask Bigbreathe Double Action IMT/PEP Bigbreathe S-IMT Bigbreathe IMT Bigbreathe Double Action V-PEP/IMT IMT/PEP 100

    Establishment Types

    Manufacture Medical Device