BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ePM 12M Monitor

    Reg #: 2221819 · FEI: 2221819 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    MINDRAY DS USA, Inc.
    Registration Number
    2221819
    FEI Number
    2221819
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    800 MACARTHUR BLVD.
    City
    Mahwah
    State
    NJ
    ZIP
    07430
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200015

    Owner / Operator

    Firm Name
    Mindray DS USA, Inc.
    Operator Number
    10025908
    Address
    800 MacArthur Blvd
    City
    Mahwah
    State
    NJ
    Postal Code
    07430
    Country
    US
    Correspondent
    James Clifford

    Products

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

    Proprietary Names

    ePM 12M Monitor ePM 12MA Monitor ePM Series Monitor ePM 10M Monitor ePM 10A Monitor ePM 15M Monitor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198