BEUDAMED
    FDA Registration Active 🇨🇳 China

    SMD-XGD/AR Galaxy

    Reg #: 3020999824 · FEI: 3020999824 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OUR SMD MEDICAL (WUHAN) CO., LTD.
    Registration Number
    3020999824
    FEI Number
    3020999824
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1, 2, 3 & 4, F1, Block B21, High-tech Medical Devices Park, No.818 Gaoxin Ave.,, East Lake High-tech Development
    City
    Wuhan Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K190844

    Owner / Operator

    Firm Name
    OUR SMD Medical (Wuhan) Co., Ltd.
    Operator Number
    10082948
    Address
    No. 3 & 4, F1, Block B21, High-tech Medical Devices Park, No.818 Gaoxin Ave., East Lake High-tech Development
    City
    Wuhan
    State
    Hubei
    Postal Code
    430223
    Country
    CN

    US Agent

    Business Name
    Akesis Inc.
    Contact Name
    Lien pham
    Address
    5129 Commercial Circle Concord, CA 94520
    City
    Concord
    State
    CA
    ZIP
    94520
    Country
    US
    Email
    [email protected]
    Phone
    925 3498782

    Products

    Device Name Product Code
    System, Radiation Therapy, Radionuclide IWB

    Proprietary Names

    SMD-XGD/AR Galaxy

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198