BEUDAMED
    FDA Registration Active 🇨🇳 China

    ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC

    Reg #: 3009156722 · FEI: 3009156722 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    8

    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
    K191769

    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
    Detector And Alarm, Arrhythmia DSI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, St Segment With Alarm MLD
    Computer, Blood-Pressure DSK
    Continuous Measurement Thermometer FLL
    Oximeter DQA
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

    Proprietary Names

    ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M)

    Establishment Types

    Manufacture Medical Device