BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Embrace2

    DI: 08538580061408 · Model: Embrace · EMPATICA SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Embrace2
    Primary DI
    08538580061408
    Version / Model
    Embrace
    Catalog Number
    EM2-SB-S
    Company Name
    EMPATICA SRL
    Labeler DUNS
    430141750
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-09
    Public Version
    2
    Public Version Date
    2020-02-12
    Public Version Status
    Update
    Public Device Record Key
    da1587c0-66cd-4e8d-ae86-e25fd9e95165
    Distribution End Date
    2020-02-11

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    POS Physiological Signal Based Seizure Monitoring System

    GMDN Terms

    Code Name
    61288 Home seizure monitoring system

    Identifiers

    Type ID
    Primary 08538580061408