BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    R3

    Reg #: 3022142628 · FEI: 3022142628 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Smith and Nephew Operations Sdn. Bhd
    Registration Number
    3022142628
    FEI Number
    3022142628
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PMT 797, Persiaran Cassia Selatan 8, Taman Perindustrian Batu Kawan, Bandar Cassia
    City
    Penang Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K092386

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL

    Proprietary Names

    R3

    Establishment Types

    Manufacture Medical Device