BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Elemental Granulate

    Reg #: 3016505723 · FEI: 3016505723 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Elemental NV
    Registration Number
    3016505723
    FEI Number
    3016505723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zuiderlaan 1 - 3 #8
    City
    Ghent Oost-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K241283

    Owner / Operator

    Firm Name
    Zinkh NV
    Operator Number
    10080587
    Address
    Zuiderlaan 1 - 3 #8
    City
    Ghent
    State
    Oost-Vlaanderen
    Postal Code
    9000
    Country
    BE

    Products

    Device Name Product Code
    Oral Wound Dressing OLR
    Cement, Dental EMA

    Proprietary Names

    Elemental Granulate Elemental PerioPlast

    Establishment Types

    Manufacture Medical Device