BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ENTIRE MEDICAL Ltd

    Reg #: 3043585137 · FEI: 3043585137 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENTIRE MEDICAL Ltd
    Registration Number
    3043585137
    FEI Number
    3043585137
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HAHOSHLIM 11
    City
    HERZLIYA Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K251996

    Owner / Operator

    Firm Name
    ENTire Medical
    Operator Number
    10095112
    Address
    HAHOSHLIM 11
    City
    HERZLIYA
    State
    Central
    Postal Code
    4672411
    Country
    IL
    Correspondent
    Daniela Heimlich

    US Agent

    Business Name
    CarboFix Orthopedics Inc
    Contact Name
    Oren Globerman
    Address
    903 N Bowser Rd Ste 330
    City
    Richardson
    State
    TX
    ZIP
    75081
    Country
    US
    Email
    [email protected]
    Phone
    901 8501337

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    ENTire IRE System

    Establishment Types

    Manufacture Medical Device