BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Pocket BVM; Pocket BVM Airway

    Reg #: 3014507910 · FEI: 3014507910 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FC COMPANY LTD
    Registration Number
    3014507910
    FEI Number
    3014507910
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Workshop 9 on 15/F Fonda Industrial Building Nos.37-39 Au Pui Wan Street Fo Tan Shatin New Territories. Hong K
    City
    Hong kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K093081

    Owner / Operator

    Firm Name
    FC Company LTD
    Operator Number
    10082490
    Address
    Workshop 9 on 15/F Fonda Industrial Building Nos.37-39 Au Pui Wan Street Fo Tan Shatin New Territories. Hong K
    City
    Hong kong
    State
    HK-NOTA
    Postal Code
    999077
    Country
    HK
    Correspondent
    Francis Chung

    US Agent

    Business Name
    Overnite Consulting Group, LLC
    Contact Name
    Steven Sonnenberg
    Address
    3405 Shelburne Rd
    City
    Pikesville
    State
    MD
    ZIP
    21208
    Country
    US
    Email
    [email protected]
    Phone
    443 9296543

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    Pocket BVM; Pocket BVM Airway Pocket BVM With O2 Tubing Pocket BVM NuMask Pocket BVM Tactical Ventilator, Emergency, Manual (Resuscitator) - Cyclone Pocket BVM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)