BEUDAMED
    FDA Registration Active 🇨🇳 China

    B-ONE MEDICAL (SUZHOU) CO., LTD.

    Reg #: 3015167917 · FEI: 3015167917 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    B-ONE MEDICAL (SUZHOU) CO., LTD.
    Registration Number
    3015167917
    FEI Number
    3015167917
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 6 Yuping Road, Science & Technology Town, New District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240528

    Owner / Operator

    Firm Name
    b-ONE Medical (Suzhou) Co., Ltd.
    Operator Number
    10059535
    Address
    No. 6 Yuping Road, Science & Technology Town, New District
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215163
    Country
    CN
    Correspondent
    Zhou He

    Products

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)