BEUDAMED
    FDA Registration Active 🇨🇳 China

    AOK Tooling Limited

    Reg #: 3006897516 · FEI: 3006897516 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    16
    Establishment Types
    5
    Classifications
    6

    Registration Details

    Registration Name
    AOK Tooling Limited
    Registration Number
    3006897516
    FEI Number
    3006897516
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101 and 1Building, 2Building, 3Building, 4Building, 5Building,, NO. 8 of Long Tian No. 3 Road, Long Tian Community, Long Tian Street, Ping Shan District,
    City
    Shen Zhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K220876

    Owner / Operator

    Firm Name
    AOK Tooling Limited
    Operator Number
    10024686
    Address
    Flat 2009, 20/F Kowloon Plaza,, No.485, Castle Peak Road, Cheung Sha Wan
    City
    Kowloon
    State
    HK-NOTA
    Postal Code
    999077
    Country
    HK
    Correspondent
    Jerry Teng

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matthew Dryden
    Address
    131 bay point dr ne
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Mask, Surgical FXX
    Respirator, Surgical MSH
    Connector, Airway (Extension) BZA
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Apparatus, Nitric Oxide Delivery MRN

    Proprietary Names

    Set Tubing and Support Ventilator AOK 95A Medical Mask (20200049) Professional Respirator 3D N95 (20160001) Professional Respirator 3D N95 B (20180022) VFold Professional Respirator N95 Ti (20180009) VFold Professional Respirator N95 (20170001) VFold Professional Respirator N95 B (20180016) M. Mask (20180021-L) Professional Respirator 3D N95 OR (20100032) V Fold N95 Mask (20190016) Hi-Ox Mask Aerosol Adapter Plain Surgical Face Mask (20190019) Neo-Verso Y CSC300 NOxFLOW sensor for use with NOxBOXi system 039 Medical Surgical Face Mask (20190039)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198