BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    GA HEALTH COMPANY LIMITED

    Reg #: 3014749926 · FEI: 3014749926 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    67
    Establishment Types
    4
    Classifications
    11

    Registration Details

    Registration Name
    GA HEALTH COMPANY LIMITED
    Registration Number
    3014749926
    FEI Number
    3014749926
    Status
    Active
    Expiry Year
    2026
    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
    K200479

    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
    Bottle, Collection And Trap, Breathing System (Uncalibrated) CBC
    Endoscopic Irrigation/Suction System OCX
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Endoscope Channel Accessory ODC
    Accessories, Cleaning Brushes, For Endoscope MNL
    Bronchoscope Accessory KTI
    Endoscopic Storage Cover OCU
    Pad, Eye HMP
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Endoscopic Bite Block MNK

    Proprietary Names

    andorate ENDO082US ENDO040US aquapulse ENDO126US ENDO092US ENDO130US ENDO230US ENDO160CO2LBUS ENDO160CO2SBUS ENDO145CO2LBUS ENDO145CO2SAUS ENDO242US ENDO018SUS ENDO037US ENDO081US ENDO028SUS ENDO046US Andorate ENDO241US ENDO004US ENDO015SUS ENDO087US ENDO038US GAR038-S, GAR075-S, & GAR105-S ENDO105US GAR301001, GAR301002, GAR301001-S & GAR301002-S Standard Hybrid Tubing with CO2 Extend 110-002CO2EXTHK Standard Hybrid Tubing with CO2 Extend 110-001CO2EXTEC Standard Hybrid Tubing with CO2 Extend 110-001CO2EXTUS Protego Air Water Bottle Tubing with CO2 Extend 202002CO2EXTUS Protego Hybrid Tubing 203002US Protego Air Water Bottle Tubing Protego Hybrid Tubing with CO2 Extend 203002CO2EXTUS Protego Air Water Connector 201002 Protego Hybrid Tubing Protego Hybrid Tubing 203001US Protego Hybrid Tubing with CO2 Extend 203001CO2EXTUS Protego SKU nos Standard Hybrid Tubing 110-002EC Standard Hybrid Tubing 110-001EC Protego Air Water Connector Protego Air Water Connector 201003 Standard Hybrid Tubing 110-002HK Protego Air Water Bottle Tubing with CO2 Extend 202001CO2EXTUS Standard Hybrid Tubing 110-001US Standard Hybrid Tubing 110-002US Protego Air Water Bottle Tubing 202002US Protego Air Water Bottle Tubing 202001US Standard Hybrid Tubing with CO2 Extend 110-002CO2EXTUS ENDO165CO2SAUS ENDO166CO2SAUS ENDO165CO2LBUS ENDO551US ENDO166CO2LBUS ENDO044US ENDO0209AUS ENDO044FUS ENDO0209US GAR3804, GAR3865, GAR105087 GAR101120, GAR101121 GAR3846,  GAR3866, GAR105092 101048,  101068, 101094 GAR101122, GAR101123 101047, 101067, 101093 GAR387546, GAR387566, GAR1057592 GAR387504, GAR387565, GAR1057587

    Establishment Types

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