BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Gynescope System

    Reg #: 3016250458 · FEI: 3016250458 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ILLUMIGYN LTD.
    Registration Number
    3016250458
    FEI Number
    3016250458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Communication Center, Neve Ilan
    City
    Neve Ilan Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K190187

    Owner / Operator

    Firm Name
    Illumigyn Ltd.
    Operator Number
    10062009
    Address
    Communication Center, Neve Ilan
    City
    Neve Ilan
    State
    Central
    Postal Code
    9085000
    Country
    IL
    Correspondent
    Gusti Averbuch

    US Agent

    Business Name
    A. Stein - Regulatory Affairs Consulting
    Contact Name
    Naphtali Deutsch
    Address
    9559 Collins Ave Apt 1007
    City
    Surfside
    State
    FL
    ZIP
    33154
    Country
    US
    Email
    [email protected]
    Phone
    888 4433867

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX
    Speculum, Vaginal, Nonmetal HIB

    Proprietary Names

    Gynescope System

    Establishment Types

    Manufacture Medical Device