BEUDAMED
    FDA Registration Active 🇨🇳 China

    VALEN II Spinal inner fixation

    Reg #: 3011805173 · FEI: 3011805173 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CHANGZHOU DINGJIAN MEDICAL APPLIANCE CO., LTD.
    Registration Number
    3011805173
    FEI Number
    3011805173
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 19 Juxiang Road, Wujin Economic Development Zone
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K143013

    Owner / Operator

    Firm Name
    Changzhou Dingjian Medical Appliance Co., Ltd.
    Operator Number
    10049634
    Address
    No. 19 Juxiang Road, Wujin Economic Development Zone
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213149
    Country
    CN
    Correspondent
    Lili LIU

    US Agent

    Business Name
    OSMUNDA TECHNOLOGY CO., LTD.
    Contact Name
    Cancan Huang
    Address
    949 White River Dr Allen
    City
    Allen
    State
    TX
    ZIP
    75013
    Country
    US
    Email
    [email protected]
    Phone
    858 3571157

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    VALEN II Spinal inner fixation VALEN Spinal inner fixation SIMER Spinal inner fixation SIMER II Spinal inner fixation

    Establishment Types

    Manufacture Medical Device