BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GalaFLEX LITE

    Reg #: 3005670760 · FEI: 3005670760 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Tepha, Incorporated
    Registration Number
    3005670760
    FEI Number
    3005670760
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    99 Hayden Avenue, Suite 360
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233999

    Owner / Operator

    Firm Name
    Tepha Inc.
    Operator Number
    10023049
    Address
    99 Hayden Ave, Suite 360
    City
    Lexington
    State
    MA
    Postal Code
    02421
    Country
    US

    Products

    Device Name Product Code
    Surgical Film OOD

    Proprietary Names

    GalaFLEX LITE

    Establishment Types

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