BEUDAMED
    FDA Registration Active 🇨🇳 China

    b-ONE Medical (Beijing) Co., Ltd.

    Reg #: 3014644608 · FEI: 3014644608 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    b-ONE Medical (Beijing) Co., Ltd.
    Registration Number
    3014644608
    FEI Number
    3014644608
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.8 West Caixiang Road, Shun Yi district
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240528

    Owner / Operator

    Firm Name
    b-ONE Medical (Beijing) Co., Ltd.
    Operator Number
    10058218
    Address
    No.8 West Caixiang Road, Shun Yi district
    City
    Beijing
    State
    CN-BJ
    Postal Code
    101300
    Country
    CN
    Correspondent
    Zhou He

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)