BEUDAMED
    FDA Registration Active 🇨🇳 China

    CANWELL MEDICAL CO., LTD.

    Reg #: 3006395932 · FEI: 3006395932 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    42

    Registration Details

    Registration Name
    CANWELL MEDICAL CO., LTD.
    Registration Number
    3006395932
    FEI Number
    3006395932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 466, South Xianhua Street.,, High-Tech Industrial Zone,
    City
    Jinhua Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242973

    Owner / Operator

    Firm Name
    Canwell Medical Co., Ltd.
    Operator Number
    10024685
    Address
    No. 466, South Xianhua Street.,, High-Tech Industrial Zone,
    City
    Jinhua
    State
    Zhejiang
    Postal Code
    321016
    Country
    CN
    Correspondent
    Ming Fang

    US Agent

    Business Name
    LLINS TECHNOLOGY INC
    Contact Name
    James Wang
    Address
    1312 17th St Pmb 2199
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    720 2171916

    Products

    Device Name Product Code
    Instrument, Manual, Surgical, General Use MDM
    Pin, Fixation, Threaded JDW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Rod, Fixation, Intramedullary And Accessories HSB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Orthopedic Manual Surgical Instrument LXH
    Screw, Fixation, Bone HWC
    Bit, Drill HTW
    Template HWT
    Tap, Bone HWX
    Plate, Fixation, Bone HRS
    Clamp HXD
    Impactor HWA
    Guide, Surgical, Instrument FZX
    Chisel, Surgical, Manual FZO
    Pin, Fixation, Smooth HTY
    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Caliper KTZ
    Driver, Prosthesis HWR
    Reamer HTO
    Extractor HWB
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Gauge, Depth HTJ

    Proprietary Names

    INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION 1.5/2/2.4 Plates 3.5 Calcaneal Plate 1.5/2/2.4/3.5 Cortex Screws 2.5/3/3.5/4/4.5/5/6.5 Headless Compression Screw 1.5/2/2.4/3.5 Locing Screws

    Establishment Types

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