BEUDAMED
    FDA Registration Active 🇨🇳 China

    BEIJING AK MEDICAL CO, LTD

    Reg #: 3013843055 · FEI: 3013843055 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    BEIJING AK MEDICAL CO, LTD
    Registration Number
    3013843055
    FEI Number
    3013843055
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.5 Wen an Street
    City
    Changping District Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K180493

    Owner / Operator

    Firm Name
    Beijing AK Medical Co, Ltd
    Operator Number
    10059173
    Address
    No.5 Wen an Street
    City
    Changping District
    State
    Beijing
    Postal Code
    102299
    Country
    CN
    Correspondent
    Shan Zhou

    US Agent

    Business Name
    SUN LUNA STAR LLC
    Contact Name
    Anna Sun
    Address
    6706 N Royce Ln
    City
    Van Nuys
    State
    CA
    ZIP
    91411
    Country
    US
    Email
    [email protected]
    Phone
    626 2005096

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    Locking Plate System A3 Total Knee System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device