BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Prelude One UD

    Reg #: 3007113445 · FEI: 3007113445 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    medmix Deutschland GmbH
    Registration Number
    3007113445
    FEI Number
    3007113445
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zum Kesselort 53
    City
    Kiel Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K111876

    Owner / Operator

    Firm Name
    medmix Deutschland GmbH
    Operator Number
    10053472
    Address
    Zum Kesselort 53
    City
    Kiel
    State
    Schleswig-Holstein
    Postal Code
    24149
    Country
    DE
    Correspondent
    Ulf Lempfert

    Products

    Device Name Product Code
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    Prelude One UD

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)