BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    UniARM

    Reg #: 3003713161 · FEI: 3003713161 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    MITAKA KOHKI CO., LTD.
    Registration Number
    3003713161
    FEI Number
    3003713161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-18-8 Nozaki
    City
    MITAKA SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K090792

    Owner / Operator

    Firm Name
    MITAKA KOHKI CO., LTD.
    Operator Number
    9035807
    Address
    1-18-8 Nozaki, --
    City
    MITAKA SHI, TOKYO
    State
    JP-NOTA
    Postal Code
    181-0014
    Country
    JP

    US Agent

    Business Name
    Mitaka USA, Inc.
    Contact Name
    Maxwell Sturgis
    Address
    842 Oakridge Road N
    City
    Park City
    State
    UT
    ZIP
    84098
    Country
    US
    Email
    [email protected]
    Phone
    435 9010515

    Products

    Device Name Product Code
    Endoscope, Neurological GWG
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    UniARM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device