BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    B.Sit Evo

    DI: 07640161460096 · Model: BEMER Therapy System Evo · Bemer Int. AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    B.Sit Evo
    Primary DI
    07640161460096
    Version / Model
    BEMER Therapy System Evo
    Catalog Number
    434200
    Company Name
    Bemer Int. AG
    Labeler DUNS
    448002860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-05
    Public Version
    1
    Public Version Date
    2025-03-13
    Public Version Status
    New
    Public Device Record Key
    6a4f67b9-8b58-42b8-b35c-ebd30e782460

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    GMDN Terms

    Code Name
    35169 Hand-held deep-tissue electromagnetic stimulator

    Identifiers

    Type ID
    Primary 07640161460096

    Premarket Submissions

    Submission Number Supplement Number
    K231368 000