BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PIOLAX MEDICAL DEVICES, INC.

    Reg #: 3002917664 · FEI: 3002917664 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PIOLAX MEDICAL DEVICES, INC.
    Registration Number
    3002917664
    FEI Number
    3002917664
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2265-3 Kamiyabe-cho Totsuka-ku
    City
    Yokohama Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170532

    Owner / Operator

    Firm Name
    Piolax Medical Devices, Inc.
    Operator Number
    10054406
    Address
    2265-3 Kamiyabe-cho Totsuka-ku
    City
    Yokohama
    State
    Kanagawa
    Postal Code
    2450053
    Country
    JP
    Correspondent
    Masumi Ogawa

    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
    Wire, Guide, Catheter DQX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)