BEUDAMED
    FDA Registration Active 🇨🇳 China

    AM-2 Aerosol Mask, Adult

    Reg #: 3006783791 · FEI: 3006783791 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GaleMed (Xiamen) Co., Ltd.
    Registration Number
    3006783791
    FEI Number
    3006783791
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road, 361026 Fujian Province, China
    City
    XIAMEN Fujian
    Country
    CN

    Owner / Operator

    Firm Name
    GaleMed Corporation
    Operator Number
    8043316
    Address
    87, LI-GONG 2ND RD.,
    City
    Wu-jia
    State
    Yilan
    Postal Code
    268
    Country
    TW

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE, St. Petersburg, FL 33704, USA
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076060

    Products

    Device Name Product Code
    Mask, Oxygen BYG

    Proprietary Names

    AM-2 Aerosol Mask, Adult OM-1 Mask, Infant w/Tubing AM-2 HiO2 Mask, Adult AM-2 Oxygen Mask, Adult Venturi, 50% O2, 22M, Orange TM-1 Trachea Mask, Adult w/Tubing OM-1 Mask, Adult OM-1 HiO2 Mask, Infant w/Tubing Venturi, 35% O2, 22M, Green OM-2 Hi-O2 Mask, Adult Venturi, 40% O2/8LPM, 22M, Red OM-5 face Tent w/Tubing LAV Venturi Mask Kit, Adult Adj Venturi (LAV) Adaptor, 22F AM-3 Adj-Venturi Mask, Child w/Tube OM-3 HiO2 Mask, Child w/Tubing, PVC Bag OM-2 HiO2 Mask, Child M1 HiO2 Mask, L M1 Oxygen Mask, M Venturi, 24% O2, 22M, Blue OM-2 PR-Mask, Adult w/Tubing Venturi, 28% O2, 22M, Yellow Venturi, 50% O2, 22F, Orange AM-3 Venturi Mask, Adult Venturi, 31% O2, 22M, White GALEMED MASK AM-2 Aerosol Mask, Child NASAL CPAP MASK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device