BEUDAMED
    FDA Registration Active 🇨🇳 China

    SYN.BODY COIL 1.5T ODU WITH SLEEVE

    Reg #: 3012439308 · FEI: 3012439308 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI CHENSHI MEDICAL INSTRUMENTS CO., LTD
    Registration Number
    3012439308
    FEI Number
    3012439308
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 206-207, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K052013

    Owner / Operator

    Firm Name
    Shanghai Chenshi Medical Instruments Co., Ltd
    Operator Number
    10058646
    Address
    Room 206-207, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201700
    Country
    CN

    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

    SYN.BODY COIL 1.5T ODU WITH SLEEVE SENSE FLEX L COIL 3T ODU SENSE FLEX M COIL 3T ODU SENSE CARDIAC COIL SHNC DRIVERBOX 1.5T ODU QUAD HEAD COIL 1.5T SENSE SPINE COIL 1.5T ODU QUAD HEAD COIL T/R 1.5T SENSE FLEX L COIL 1.5T ODU SENSE FLEX S COIL 3T ODU SENSE FLEX M COIL 1.5T ODU SHNC DRIVERBOX 1.5T SENSE FLEX S COIL 1.5T ODU SYN.BODY COIL 1.5T ODU SYN.BODY COIL 1.5T WITH SLEEVE SENSE SPINE COIL 1.5T

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device