BEUDAMED
    FDA Registration Active 🇨🇳 China

    Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi Diagnostic Ultrasound System

    Reg #: 3009156722 · FEI: 3009156722 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
    Registration Number
    3009156722
    FEI Number
    3009156722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1203 Nanhuan Avenue, Guangming District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240115

    Owner / Operator

    Firm Name
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Operator Number
    9058402
    Address
    MINDRAY BUILDING,KEJI 12TH RD., SOUTH, HI-TECH INDUSTRIAL PARK
    City
    NANSHAN, SHENZHEN, GUANGDONG
    State
    CN-GD
    Postal Code
    518057
    Country
    CN

    US Agent

    Business Name
    Mindray DS USA, Inc
    Contact Name
    James Clifford
    Address
    800 MacArthur Blvd
    City
    Mahwah
    State
    NJ
    ZIP
    07430
    Country
    US
    Email
    [email protected]
    Phone
    201 6709353

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi Diagnostic Ultrasound System Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp Diagnostic Ultrasound System Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Nuewa IY Diagnostic Ultrasound System

    Establishment Types

    Manufacture Medical Device