BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    3D-Shaper

    Reg #: 3026043045 · FEI: 3026043045 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3D-SHAPER MEDICAL S.L.
    Registration Number
    3026043045
    FEI Number
    3026043045
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rambla Catalunya, 53, 4-H
    City
    Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K220822

    Owner / Operator

    Firm Name
    3D-Shaper Medical S.L.
    Operator Number
    10087195
    Address
    Rambla Catalunya, 53, 4-H
    City
    Barcelona
    State
    ES-B
    Postal Code
    08007
    Country
    ES
    Correspondent
    Ludovic Humbert

    US Agent

    Business Name
    Carrasco
    Contact Name
    Mateo Carrasco
    Address
    1815 Barker Drive
    City
    Winter Park
    State
    FL
    ZIP
    32789
    Country
    US
    Email
    [email protected]
    Phone
    407 2849480

    Products

    Device Name Product Code
    Densitometer, Bone KGI

    Proprietary Names

    3D-Shaper

    Establishment Types

    Manufacture Medical Device