BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Evoke(R) Tunneling Tool

    Reg #: 3021836309 · FEI: 3021836309 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Saluda Medical Pty. Ltd.
    Registration Number
    3021836309
    FEI Number
    3021836309
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Eden Park Drive
    City
    Macquarie Park New South Wales
    Country
    AU

    Regulatory Submissions

    PMA Number
    P190002

    Owner / Operator

    Firm Name
    Saluda Medical Pty Ltd
    Operator Number
    10061701
    Address
    5 Eden Park Drive
    City
    Macquarie Park
    State
    New South Wales
    Postal Code
    2113
    Country
    AU

    US Agent

    Business Name
    N/A
    Contact Name
    N/A
    Address
    N/A, N/A
    City
    N/A
    State
    NA
    ZIP
    N/A
    Country
    US
    Email
    N/A

    Products

    Device Name Product Code
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB

    Proprietary Names

    Evoke(R) Tunneling Tool Evoke(R) 12C Percutaneous Trial Lead Kit Evoke(R) 12C Lead Extension Kit Evoke(R) eCLS Case Evoke(R) Charger Evoke(R) Intraoperative Cable Kit Evoke(R) External Closed-Loop Stimulator Evoke(R) Clinical System Transceiver Evoke(R) 12C Percutaneous Lead Kit Evoke(R) Epidural Needle Evoke(R) Accessory Belt Evoke(R) Closed-Loop Stimulator Evoke(R) Clinical Interface Evoke(R) Patient Controller Evoke(R) eCLS Battery Charger Kit Evoke(R) Lead Adapter Kit

    Establishment Types

    Manufacture Medical Device