BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    MICROPACE PTY. LTD.

    Reg #: 3003617581 · FEI: 3003617581 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    MICROPACE PTY. LTD.
    Registration Number
    3003617581
    FEI Number
    3003617581
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    41/159 Arthur Street
    City
    Homebush West New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K011826

    Owner / Operator

    Firm Name
    MICROPACE PTY. LTD.
    Operator Number
    9044248
    Address
    41/159 Arthur Street
    City
    Homebush West
    State
    New South Wales
    Postal Code
    2140
    Country
    AU
    Correspondent
    MICHAEL - CEJNAR

    US Agent

    Business Name
    Micropace EP, Inc.
    Contact Name
    Michelle Le
    Address
    3205 W Warner Ave
    City
    Santa Ana
    State
    CA
    ZIP
    92704
    Country
    US
    Email
    [email protected]
    Phone
    714 2587025

    Products

    Device Name Product Code
    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) JOQ
    Cable, Electrode IKD

    Proprietary Names

    EPS320 CARDIAC STIMULATOR STIMCOR CARDIAC STIMULATOR SGU Replacement Spares for EPS320 Family ORLAB Cardiac Stimulator STIMLAB Cardiac Stimulator OneLINK Splitter Cable MedConnect Adaptor Cable EP Y Adaptor Cable StimLab Cardiac Stimulator

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198