BEUDAMED
    FDA Registration Active 🇨🇳 China

    ePM Series Patient Monitors (Including ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC)

    Reg #: 3007603826 · FEI: 3007603826 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    Shenzhen Mindray Bio-Medical Electronics Co.,LTD
    Registration Number
    3007603826
    FEI Number
    3007603826
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MINDRAY BUILDING,KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK,NANSHAN
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K200015

    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
    Correspondent
    Xinbing Wang

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

    Proprietary Names

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

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility