BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Dr.Pen

    DI: 06976749540012 · Model: A20 · GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dr.Pen
    Primary DI
    06976749540012
    Version / Model
    A20
    Company Name
    GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD.
    Labeler DUNS
    551479834
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-06
    Public Version
    4
    Public Version Date
    2026-01-01
    Public Version Status
    Update
    Public Device Record Key
    dffe4d1a-248e-4c33-b551-b4bd62969be8
    Distribution End Date
    2026-01-01

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    High-level Disinfectant

    Product Codes

    Code Name
    QAI Powered Microneedle Device

    GMDN Terms

    Code Name
    61216 Cosmetic micro-needling electronic handpiece, professional

    Identifiers

    Type ID
    Primary 06976749540012