BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    ENDO081US

    Reg #: 3014749926 · FEI: 3014749926 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    GA HEALTH COMPANY LIMITED
    Registration Number
    3014749926
    FEI Number
    3014749926
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza, 138 Shatin Rural Committee Road, Shatin, N.T.
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K191231

    Owner / Operator

    Firm Name
    GA Health Company Limited
    Operator Number
    10061258
    Address
    Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza,, 138 Shatin Rural Committee Road, Shatin, N.T.
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    None
    Country
    HK

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Endoscopic Irrigation/Suction System OCX
    Endoscope Channel Accessory ODC

    Proprietary Names

    ENDO081US ENDO018SUS andorate ENDO242US ENDO037US

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198