BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Radifocus Glidewire Advantage

    Reg #: 3013611763 · FEI: 3013611763 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Terumo Yamaguchi Corporation
    Registration Number
    3013611763
    FEI Number
    3013611763
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-22 Sayama-Aza-Murayama,
    City
    Yamaguchi-shi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K063372

    Owner / Operator

    Firm Name
    TERUMO CORP.
    Operator Number
    8010026
    Address
    44-1, 2-CHOME, HATAGAYA, --
    City
    SHIBUYA-KU, TOKYO
    State
    JP-NOTA
    Postal Code
    151-0072
    Country
    JP

    US Agent

    Business Name
    Terumo Medical Corp
    Contact Name
    Dina Justice
    Address
    950 Elkton Blvd.
    City
    Elkton
    State
    MD
    ZIP
    21921
    Country
    US
    Email
    [email protected]
    Phone
    410 3927226

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Radifocus Glidewire Advantage

    Establishment Types

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