BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Luna G3 APAP; Luna G3 CPAP

    Reg #: 3033530343 · FEI: 3033530343 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BMC INVESTMENT HOLDING LIMITED
    Registration Number
    3033530343
    FEI Number
    3033530343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROOM 747, 7/F STAR HOUSE, 3 SALISBURY ROAD, TSIM SHA TSUI, KOWLOON,HK
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K201620

    Owner / Operator

    Firm Name
    BMC Investment Holding Limited
    Operator Number
    10091606
    Address
    ROOM 747, 7/F STAR HOUSE, 3 SALISBURY ROAD, TSIM SHA TSUI, KOWLOON,HK
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    999077
    Country
    HK
    Correspondent
    Chengwei Gao

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Luna G3 APAP; Luna G3 CPAP Luna G3 BPAP 25A

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device