BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Steriject

    Reg #: 3012854006 · FEI: 3012854006 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    TSK LABORATORY, JAPAN
    Registration Number
    3012854006
    FEI Number
    3012854006
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1510-1 SOJA-MACHI
    City
    TOCHIGI-SHI
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K970370

    Owner / Operator

    Firm Name
    TSK LABORATORY, JAPAN
    Operator Number
    9008437
    Address
    1510-1 Soja-Machi, --
    City
    TOCHIGI-SHI, TOCHIGI-KEN
    State
    JP-09
    Postal Code
    328-0002
    Country
    JP

    US Agent

    Business Name
    Johnson Global California
    Contact Name
    Norman Shane Johnson
    Address
    17280 Newhope Street, Suite 16
    City
    Fountain Valley
    State
    CA
    ZIP
    92708
    Country
    US
    Email
    [email protected]
    Phone
    714 7140294

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Steriject Sterijekt

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device