BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PuraGel

    Reg #: 3007162658 · FEI: 3007162658 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3-D MATRIX, LTD.
    Registration Number
    3007162658
    FEI Number
    3007162658
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kojimachi-HF Building 7F, Kojimachi 3-2-4
    City
    Chiyoda-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K183015

    Owner / Operator

    Firm Name
    3-D Matrix, Ltd.
    Operator Number
    10061211
    Address
    Kojimachi-HF Building 7F, Kojimachi 3-2-4
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    102-0083
    Country
    JP
    Correspondent
    Ken Oguro

    US Agent

    Business Name
    3D-Matrix
    Contact Name
    Alan Miskewicz
    Address
    1234 Chestnut Street, Suite 205
    City
    Newton
    State
    MA
    ZIP
    02464
    Country
    US
    Email
    [email protected]
    Phone
    781 3739020

    Products

    Device Name Product Code
    Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB

    Proprietary Names

    PuraGel

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device