BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Elara II, 5075 HSG MD

    Reg #: 2435367 · FEI: 2435367 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K143311

    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

    Elara II, 5075 HSG MD

    Establishment Types

    Manufacture Medical Device