BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Datrix LLC

    Reg #: 2028530 · FEI: 1000125122 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Datrix LLC
    Registration Number
    2028530
    FEI Number
    1000125122
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    382 State Pl
    City
    Escondido
    State
    CA
    ZIP
    92029
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112601

    Owner / Operator

    Firm Name
    Datrix LLC
    Operator Number
    10054495
    Address
    382 State pl.
    City
    Escondido
    State
    CA
    Postal Code
    92029
    Country
    US
    Correspondent
    Jon Barron

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    Sirona CardioHolter AT MyCardia AT GEMS Sirona Sentinel EX1000 Centauri VX3+

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility