BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Steriject

    Reg #: 3006850123 · FEI: 3006850123 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JAPAN IRRADIATION SERVICE CO., LTD
    Registration Number
    3006850123
    FEI Number
    3006850123
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2600, Ishigami-tojuku, Tokai-mura
    City
    Naka-gun Ibaraki
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K970370

    Owner / Operator

    Firm Name
    Japan Irradiation Service Co., Ltd
    Operator Number
    10050128
    Address
    2600, Ishigami-tojuku, Tokai-mura
    City
    Naka-gun
    State
    Ibaraki
    Postal Code
    319-1101
    Country
    JP
    Correspondent
    Hiroshi Umetsu

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Steriject Sterijekt

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)