BEUDAMED
    FDA Registration Active 🇨🇳 China

    SENSE SPINE COIL 1.5T ODU 4522-133-1724X

    Reg #: 3006239787 · FEI: 3006239787 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Registration Number
    3006239787
    FEI Number
    3006239787
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1269, Huaqing Road, Qingpu District
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K052013

    Owner / Operator

    Firm Name
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO., LTD.
    Operator Number
    9093889
    Address
    No. 1269, Huaqing Road, Qingpu District
    City
    SHANGHAI
    State
    CN-SH
    Postal Code
    201707
    Country
    CN
    Correspondent
    Jie Huang

    US Agent

    Business Name
    IRC USA
    Contact Name
    CHARLES MACK
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    SENSE SPINE COIL 1.5T ODU 4522-133-1724X SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-000-5189X SENSE CARDIAC COIL 1.5T ODU 4522-133-1726X QUAD HEAD COIL 1.5T 4522-133-1727X QUAD HEAD COIL T/R 1.5T 4598-002-0529X SENSE FLEX M COIL 1.5T ODU 4522-133-1717X

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)