BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI CHENSHI MEDICAL INSTRUMENTS CO., LTD

    Reg #: 3012439308 · FEI: 3012439308 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    SHANGHAI CHENSHI MEDICAL INSTRUMENTS CO., LTD
    Registration Number
    3012439308
    FEI Number
    3012439308
    Status
    Active
    Expiry Year
    2026
    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
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    QUAD HEAD COIL 1.5T SENSE FLEX S COIL 1.5T ODU SENSE FLEX L COIL 3T ODU SYN.BODY COIL 1.5T ODU SENSE CARDIAC COIL SENSE FLEX M COIL 3T ODU SENSE FLEX M COIL 1.5T ODU SYN.BODY COIL 1.5T ODU WITH SLEEVE SENSE FLEX L COIL 1.5T ODU SENSE FLEX S COIL 3T ODU SYN.BODY COIL 1.5T WITH SLEEVE SENSE SPINE COIL 1.5T SHNC DRIVERBOX 1.5T ODU QUAD HEAD COIL T/R 1.5T SHNC DRIVERBOX 1.5T SENSE SPINE COIL 1.5T ODU Pediatric Body-Cardiac Coil (4522-150-41131) Pediatric Head-Spine Coil (4522-133-18981) Pediatric Head-Spine Coil (Model: 5000012701) Knee/Foot/Ankle Coil, multiple types Pediatric Head-Spine Coil (4522-150-41161) Pediatric Body-Cardiac Coil (4522-133-18721) Pediatric Body-Cardiac Coil (Model: 5000012601) QUAD HEAD COIL T/R 3T

    Establishment Types

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