BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    X100

    Reg #: 3018182832 · FEI: 3018182832 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SCOPIO LABS LTD.
    Registration Number
    3018182832
    FEI Number
    3018182832
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 Hasharon St.
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K201301

    Owner / Operator

    Firm Name
    Scopio Labs Ltd.
    Operator Number
    10080474
    Address
    10 Hasharon St.
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6618502
    Country
    IL
    Correspondent
    Amy Meitus

    US Agent

    Business Name
    Scopio Labs Inc.
    Contact Name
    Itai Hayut
    Address
    7 Becker Farm Rd
    City
    Roseland
    State
    NJ
    ZIP
    07068
    Country
    US
    Email
    [email protected]
    Phone
    203 6925021

    Products

    Device Name Product Code
    Device, Automated Cell-Locating JOY

    Proprietary Names

    X100 Full Field PBS X100 with Full Field Peripheral Blood Smear (PBS) Application

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198