BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Gel-One

    Reg #: 9612392 · FEI: 1000255210 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SEIKAGAKU CORPORATION, TAKAHAGI PLANT
    Registration Number
    9612392
    FEI Number
    1000255210
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    258-5, AZA-MATSUKUBO, OAZA-AKAHAMA
    City
    TAKAHAGI-SHI Ibaraki
    Country
    JP

    Regulatory Submissions

    PMA Number
    P080020

    Owner / Operator

    Firm Name
    SEIKAGAKU CORPORATION
    Operator Number
    9043759
    Address
    6-1, Marunouchi 1-chome, Chiyoda-ku
    City
    Tokyo
    State
    JP-NOTA
    Postal Code
    100-0005
    Country
    JP
    Correspondent
    Hiroshi - Murase

    US Agent

    Business Name
    NELSON MULLINS RILEY & SCARBOROUGH LLP
    Contact Name
    Thomas Bardo
    Address
    101 Constitution Avenue, NW/Suite 900
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    202 6892817

    Products

    Device Name Product Code
    Acid, Hyaluronic, Intraarticular MOZ

    Proprietary Names

    Gel-One

    Establishment Types

    Manufacture Medical Device