BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X100HT System

    DI: 07290118610892 · Model: SC-SYS-00017 · SCOPIO LABS LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X100HT System
    Primary DI
    07290118610892
    Version / Model
    SC-SYS-00017
    Company Name
    SCOPIO LABS LTD
    Labeler DUNS
    600369986
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-01
    Public Version
    3
    Public Version Date
    2025-08-22
    Public Version Status
    Update
    Public Device Record Key
    8bc1c6e3-9a26-4b72-9ea5-8a72a4360ae5

    Device Description

    X100HT with Processing Unit and a Maintenance Kit. Includes: - X100HT Scanner - X100HT Processing Unit - X100HT User Maintenance Kit

    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
    Yes
    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
    JOY Device, Automated Cell-Locating
    SAL Device, Automated Cell Locating, Bone Marrow

    GMDN Terms

    Code Name
    61864 Cell morphology analyser IVD, automated/semi-automated

    Identifiers

    Type ID
    Primary 07290118610892

    Premarket Submissions

    Submission Number Supplement Number
    K201301 000
    K220013 000
    K243144 000