BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    PRECISION GI 20GA Motorized EUS Biopsy Device

    Reg #: 3029779285 · FEI: 3029779285 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LIMACA MEDICAL LTD
    Registration Number
    3029779285
    FEI Number
    3029779285
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Ha' Rimon st, Regev Bldg., Mevo Carmel High Tech Park
    City
    Ein Ha Emeq Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K231422

    Owner / Operator

    Firm Name
    Limaca medical Ltd
    Operator Number
    10088881
    Address
    3 Ha' Rimon st, Regev Bldg., Mevo Carmel High Tech Park
    City
    Ein Ha Emeq
    State
    Haifa
    Postal Code
    1925000
    Country
    IL
    Correspondent
    Assaf Klein

    US Agent

    Business Name
    SFADC, LLC
    Contact Name
    Susan Alpert
    Address
    2425 L Street NW, Apt. 307
    City
    Washington
    State
    DC
    ZIP
    20037
    Country
    US
    Email
    [email protected]
    Phone
    612 2027019

    Products

    Device Name Product Code
    Biopsy Needle FCG

    Proprietary Names

    PRECISION GI 20GA Motorized EUS Biopsy Device

    Establishment Types

    Manufacture Medical Device