BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Amoena

    Reg #: 3005855077 · FEI: 3005855077 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Amoena USA Corporation
    Registration Number
    3005855077
    FEI Number
    3005855077
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1000 Cobb Place Blvd. Ste. 200
    City
    Kennesaw
    State
    GA
    ZIP
    30144
    Country
    US

    Owner / Operator

    Firm Name
    AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH
    Operator Number
    9105040
    Address
    KAPELLENWEG 36, --
    City
    RAUBLING, BAVARIA
    State
    DE-NOTA
    Postal Code
    D-83064
    Country
    DE
    Correspondent
    ANDREAS - LINKE

    Products

    Device Name Product Code
    Prosthesis, Breast, External, Used With Adhesive KCZ

    Proprietary Names

    Amoena

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198