BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bioserenity Cloud

    DI: 03615220004270 · Model: 1012-21002-US · BIOSERENITY MEDICAL DEVICES GROUP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bioserenity Cloud
    Primary DI
    03615220004270
    Version / Model
    1012-21002-US
    Company Name
    BIOSERENITY MEDICAL DEVICES GROUP
    Labeler DUNS
    281224773
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-15
    Public Version
    4
    Public Version Date
    2023-12-28
    Public Version Status
    Update
    Public Device Record Key
    a5f788d4-96ff-4c03-b4fe-c63bf33b503f

    Device Description

    Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals.

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    No

    Product Codes

    Code Name
    OUG Medical Device Data System

    GMDN Terms

    Code Name
    46564 Bio-energy preliminary diagnosis system application software

    Identifiers

    Type ID
    Primary 03615220004270