BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Silagen Silicone Sheeting

    Reg #: 3005369309 · FEI: 3005369309 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NEWMEDICAL TECHNOLOGY, INC.
    Registration Number
    3005369309
    FEI Number
    3005369309
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4065 Commercial Avenue
    City
    NORTHBROOK
    State
    IL
    ZIP
    60062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041704

    Owner / Operator

    Firm Name
    NEWMEDICAL TECHNOLOGY, INC.
    Operator Number
    9064417
    Address
    4065 Commercial Avenue, --
    City
    Northbrook
    State
    IL
    Postal Code
    60062
    Country
    US
    Correspondent
    A. MICHAEL - HANNA

    Products

    Device Name Product Code
    Elastomer, Silicone, For Scar Management MDA

    Proprietary Names

    Silagen Silicone Sheeting NewGel+ Silicone Sheeting NXGEL Silicone Sheeting

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device