BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TM0539AE

    Reg #: 3014498725 · FEI: 3014498725 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NEMOTO NORTH AMERICA, INC.
    Registration Number
    3014498725
    FEI Number
    3014498725
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    37160 Sugar Ridge Rd
    City
    North Ridgeville
    State
    OH
    ZIP
    44039
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242212

    Owner / Operator

    Firm Name
    Nemoto North America, Inc.
    Operator Number
    10057761
    Address
    37160 Sugar Ridge Road
    City
    North Ridgeville
    State
    OH
    Postal Code
    44039
    Country
    US
    Correspondent
    James Farmer

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    TM0539AE Disposable Syringe (Kit) TM0539K TM0544W TM0539003 Nemoto Disposable Syringe (Kit) TM0544C TM0539L TM0539M TM0539P TM0539S TM0539010

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility