BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMD - Pack, Hot or Cold, Disposable - DeRoyal

    Reg #: 1043214 · FEI: 1043214 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DEROYAL INDUSTRIES, INC.
    Registration Number
    1043214
    FEI Number
    1043214
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    200 DEBUSK LN.
    City
    POWELL
    State
    TN
    ZIP
    37849
    Country
    US

    Regulatory Submissions

    510(k) Number
    K980509

    Owner / Operator

    Firm Name
    DEROYAL INDUSTRIES, INC.
    Operator Number
    1044833
    Address
    200 DEBUSK LN., --
    City
    Powell
    State
    TN
    Postal Code
    37849
    Country
    US
    Correspondent
    Elizabeth Reed

    Products

    Device Name Product Code
    Pack, Hot Or Cold, Disposable IMD

    Proprietary Names

    IMD - Pack, Hot or Cold, Disposable - DeRoyal

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility