BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    DBB-06 Hemodialysis Delivery System

    Reg #: 8031561 · FEI: 3002807721 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIKKISO CO., LTD. - SHIZUOKA PLANT
    Registration Number
    8031561
    FEI Number
    3002807721
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    498-1 SHIZUTANI, MAKINOHARA-SHI
    City
    SHIZUOKA-KEN
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K152938

    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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    DBB-06 Hemodialysis Delivery System

    Establishment Types

    Manufacture Medical Device