BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    3D SYSTEMS - LAYERWISE

    Reg #: 3010705004 · FEI: 3010705004 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3D SYSTEMS - LAYERWISE
    Registration Number
    3010705004
    FEI Number
    3010705004
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Grauwmeer 14
    City
    Heverlee Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K192168

    Owner / Operator

    Firm Name
    LayerWise nv
    Operator Number
    10048431
    Address
    Grauwmeer 14
    City
    Heverlee
    State
    Vlaams Brabant
    Postal Code
    3001
    Country
    BE
    Correspondent
    Benjamin Johnson

    US Agent

    Business Name
    3D Systems - Medical Modeling
    Contact Name
    Benjamin Johnson
    Address
    5381 S Alkire Circle
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 6431001

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)