BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    PainChek Ltd.

    Reg #: 3022518366 · FEI: 3022518366 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    PainChek Ltd.
    Registration Number
    3022518366
    FEI Number
    3022518366
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Suite 401, 35 Lime Street
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    DEN240073

    Owner / Operator

    Firm Name
    PainChek Ltd.
    Operator Number
    10094224
    Address
    Suite 401, 35 Lime Street
    City
    Sydney
    State
    New South Wales
    Postal Code
    2000
    Country
    AU
    Correspondent
    Caleb Ng

    Products

    Device Name Product Code
    Pain Assessment Software In Non-Communicative Adults SGB

    Proprietary Names

    PainChek Adult

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device