BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    3DI INCLUDING CSCORE

    Reg #: 3006551230 · FEI: 3006551230 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHINA SYSTEMS LTD.
    Registration Number
    3006551230
    FEI Number
    3006551230
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 Haeshel ST. P.O.Box 3072,, CAESAREA INDUSTRIAL PARK SOUTH
    City
    CAESAREA, 3079504 Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K112530

    Owner / Operator

    Firm Name
    SHINA SYSTEMS LTD.
    Operator Number
    9097024
    Address
    7 Haheshel ST.,, INDUSTRIAL PARK SHOUTH
    City
    CAESAREA,
    State
    Haifa
    Postal Code
    3079504
    Country
    IL
    Correspondent
    NAOR SHINA

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    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
    System, Image Processing, Radiological LLZ

    Proprietary Names

    3DI INCLUDING CSCORE

    Establishment Types

    Manufacture Medical Device