BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Elemental NV

    Reg #: 3016505723 · FEI: 3016505723 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Elemental NV
    Registration Number
    3016505723
    FEI Number
    3016505723
    Status
    Active
    Expiry Year
    2026
    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
    Wax, Dental, Intraoral EGD

    Proprietary Names

    Elemental PerioPlast Elemental Granulate

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device