BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI KiNETIC MEDICAL CO LTD

    Reg #: 3010071016 · FEI: 3010071016 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    19

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    Registration Details

    Registration Name
    SHANGHAI KiNETIC MEDICAL CO LTD
    Registration Number
    3010071016
    FEI Number
    3010071016
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2F, No.23 Building, 528 Ruiqing Road, East Zhangjiang High-Tech Park;, No.508, Tianchen Rd., Xianghuaqiao Street, Qingpu
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K113742

    Owner / Operator

    Firm Name
    Shanghai Kinetic Medical Co LTD
    Operator Number
    10050980
    Address
    2F, No.23 Building, 528 Ruiqing Road, East Zhangjiang High-Tech Park
    City
    East Zhangjiang
    State
    Shanghai
    Postal Code
    201201
    Country
    CN
    Correspondent
    Halley Feng

    US Agent

    Business Name
    Regulatory Strategies, Inc.
    Contact Name
    Gregory Mathison
    Address
    3924 Cascade Beach Rd
    City
    Lutsen
    State
    MN
    ZIP
    55612
    Country
    US
    Email
    [email protected]
    Phone
    218 3871559

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Rongeur HTX
    Cannula, Surgical, General & Plastic Surgery GEA
    Dissector, Surgical, General & Plastic Surgery GDI
    Cement, Bone, Vertebroplasty NDN
    Arthroscope HRX
    Pusher, Socket HXO
    Probe HXB
    Handle, Scalpel GDZ
    Needle, Aspiration And Injection, Disposable GAA
    Elevator, Surgical, General & Plastic Surgery GEG
    Passer, Wire, Orthopedic HXI
    Chisel, Surgical, Manual FZO
    Instrument, Manual, Surgical, General Use MDM
    Curette, Surgical, General Use FZS
    Dilator, Catheter GCC
    Trephine HWK
    Retractor GAD
    Device, Percutaneous, Biopsy MJG

    Proprietary Names

    Sterilization Tray Kerrison Working Port Dilator Cannula Dissector KMC Kyphoplasty System Pusher/Extender Nerve Probe Handle One-shot Bone Drill Freer Elevator K-wire Chisel Suction Tube Grasper Curette Coaxial Step Dilator Trephine RETRACTOR Bone Biopsy Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device