BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    NIKKISO CO., LTD. - SHIZUOKA PLANT

    Reg #: 8031561 · FEI: 3002807721 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    NIKKISO CO., LTD. - SHIZUOKA PLANT
    Registration Number
    8031561
    FEI Number
    3002807721
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    498-1 SHIZUTANI, MAKINOHARA-SHI
    City
    SHIZUOKA-KEN
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K231589

    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

    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
    Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients PBN
    Accessories, Blood Circuit, Hemodialysis KOC
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Lipoprotein, Low Density, Removal MMY

    Proprietary Names

    LIPOSORBER LA-15 System AV06C-E Blood Tubing Lines for Hemodialysis Liposorber LA-15 system DIALYSATE FILTERS DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198