BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    INITIA, LTD.

    Reg #: 3017140415 · FEI: 3017140415 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    INITIA, LTD.
    Registration Number
    3017140415
    FEI Number
    3017140415
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Nevatim Str.
    City
    Petah Tikva Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K053640

    Owner / Operator

    Firm Name
    Initia, Ltd.
    Operator Number
    10075838
    Address
    10 Nevatim Str., Petah Tikva, Central, 4956106, ISRAEL
    City
    Petah Tikva
    State
    Tel Aviv
    Postal Code
    4956106
    Country
    IL

    US Agent

    Business Name
    FDAbasics LLC
    Contact Name
    Jerry Doane
    Address
    15815 Sw 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Integra Integra SL Magna MoreNova PRO (10-MPRB-000) MoreNova DT (10-MRNV-000)

    Establishment Types

    Manufacture Medical Device