BEUDAMED
    FDA Registration Active 🇨🇳 China

    PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

    Reg #: 3011423165 · FEI: 3011423165 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3011423165
    FEI Number
    3011423165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1451, 1st Biyuan Road, High-tech District,
    City
    Xi'an Shaanxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K214109

    Owner / Operator

    Firm Name
    Kontour (Xi'an) Medical Technology Co., Ltd.
    Operator Number
    10062728
    Address
    No.1451, 1st Biyuan Road, High-tech District,
    City
    Xi'an
    State
    Shaanxi
    Postal Code
    710065
    Country
    CN
    Correspondent
    rongrong cong

    Products

    Device Name Product Code
    Plate, Cranioplasty, Preformed, Non-Alterable GXN

    Proprietary Names

    PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)