BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BERKLEY MEDICAL RESOURCES, INC.

    Reg #: 2518423 · FEI: 2518423 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    BERKLEY MEDICAL RESOURCES, INC.
    Registration Number
    2518423
    FEI Number
    2518423
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    700 Mountain View Dr
    City
    Smithfield
    State
    PA
    ZIP
    15478
    Country
    US

    Regulatory Submissions

    510(k) Number
    K922716

    Owner / Operator

    Firm Name
    BERKLEY MEDICAL RESOURCES, INC.
    Operator Number
    2518423
    Address
    700 Mountainview Drive, --
    City
    Smithfield
    State
    PA
    Postal Code
    15478
    Country
    US
    Correspondent
    Domenic A Tommarello

    Products

    Device Name Product Code
    Mask, Surgical FXX
    Dress, Surgical FYE

    Proprietary Names

    Klear Vision Surgical Apparel

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198