BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    NIKKISO CO., LTD.

    Reg #: 3014638255 · FEI: 3014638255 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIKKISO CO., LTD.
    Registration Number
    3014638255
    FEI Number
    3014638255
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20-3 EBISU 4-CHOME,
    City
    SHIBUYA-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K242176

    Owner / Operator

    Firm Name
    NIKKISO CO., LTD.
    Operator Number
    8031561
    Address
    20-3 EBISU 4-CHOME,
    City
    SHIBUYA-KU
    State
    Tokyo
    Postal Code
    150-6022
    Country
    JP
    Correspondent
    Satoko Hina

    US Agent

    Business Name
    MIC International
    Contact Name
    Deno Zachary
    Address
    201 East 69th Street, Suite 5O,
    City
    New York
    State
    NY
    ZIP
    10021
    Country
    US
    Email
    [email protected]
    Phone
    917 3315789

    Products

    Device Name Product Code
    Accessories, Blood Circuit, Hemodialysis KOC

    Proprietary Names

    AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AV06C-E Blood Tubing Lines for Hemodialysis Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility