BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PENTAX Single Use Balloon OF-A67

    Reg #: 3017140456 · FEI: 3017140456 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TOCHIGICHIZUKA PLANT
    Registration Number
    3017140456
    FEI Number
    3017140456
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1705 CHIZUKA-MACHI
    City
    Chizuka, Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K130247

    Owner / Operator

    Firm Name
    Fuji Latex Co., LTD.
    Operator Number
    10029059
    Address
    19-1, 3-chome, Kanda Nishiki-cho, Chiyoda-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    101-0054
    Country
    JP

    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
    Transducer, Ultrasonic, Diagnostic ITX
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG

    Proprietary Names

    PENTAX Single Use Balloon OF-A67

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)