BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    AccuBrain, model: AccuBrain_Intl

    Reg #: 3018211796 · FEI: 3018211796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BRAINNOW MEDICAL TECHNOLOGY LIMITED
    Registration Number
    3018211796
    FEI Number
    3018211796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UNIT 535A 5/F CORE BUILDING 2 NO.1 SCIENCE PARK WEST AVENUE HK SCIENCE PARK PAK SHEK KOK NT
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K202847

    Owner / Operator

    Firm Name
    BrainNow Medical Technology Limited
    Operator Number
    10080294
    Address
    UNIT 535A 5/F CORE BUILDING 2 NO.1 SCIENCE PARK WEST AVENUE HK SCIENCE PARK PAK SHEK KOK NT
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    999077
    Country
    HK
    Correspondent
    Junbin Huang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    AccuBrain, model: AccuBrain_Intl

    Establishment Types

    Manufacture Medical Device