BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    BIOPSY DIGIT

    Reg #: 9680027 · FEI: 3002807317 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMS GIOTTO S.p.A.
    Registration Number
    9680027
    FEI Number
    3002807317
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Sagittario, 5
    City
    Sasso Marconi Bologna
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K990192

    Owner / Operator

    Firm Name
    IMS GIOTTO S.p.A.
    Operator Number
    10028474
    Address
    Via Sagittario, 5
    City
    Sasso Marconi
    State
    Bologna
    Postal Code
    40037
    Country
    IT
    Correspondent
    Antonella Rossi

    US Agent

    Business Name
    THEMA CORP
    Contact Name
    Silvia Tamarri
    Address
    2929 Arch Street
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US
    Email
    [email protected]
    Phone
    215 8459459

    Products

    Device Name Product Code
    System, X-Ray, Mammographic IZH

    Proprietary Names

    BIOPSY DIGIT

    Establishment Types

    Manufacture Medical Device