BEUDAMED
    FDA Registration Active 🇺🇸 United States

    T-Edge 11 120V

    Reg #: 2435367 · FEI: 2435367 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TUTTNAUER USA CO. LTD.
    Registration Number
    2435367
    FEI Number
    2435367
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    345 Oser Avenue, --
    City
    HAUPPAUGE
    State
    NY
    ZIP
    11788
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213080

    Owner / Operator

    Firm Name
    TUTTNAUER USA CO. LTD.
    Operator Number
    1450514
    Address
    345 Oser Avenue, --
    City
    Hauppauge
    State
    NY
    Postal Code
    11788
    Country
    US
    Correspondent
    Keren Ziv

    Products

    Device Name Product Code
    Sterilizer, Steam FLE

    Proprietary Names

    T-Edge 11 120V T-Edge 10 120V T-Edge 11 230V T-Edge 10 230V

    Establishment Types

    Manufacture Medical Device