BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Saluda Medical Pty. Ltd.

    Reg #: 3021836309 · FEI: 3021836309 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Saluda Medical Pty. Ltd.
    Registration Number
    3021836309
    FEI Number
    3021836309
    Status
    Active
    Expiry Year
    2026
    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
    Saluda Medical Pty Ltd
    Contact Name
    John Daley
    Address
    9401 James Ave S Ste 132
    City
    Bloomington
    State
    MN
    ZIP
    55431
    Country
    US
    Email
    [email protected]
    Phone
    508 2595100

    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
    Stimulator, Electrical, Implantable, For Incontinence EZW

    Proprietary Names

    Evoke(R) Lead Adapter Kit Evoke(R) 12C Percutaneous Trial Lead Kit Evoke(R) Accessory Belt Evoke(R) eCLS Case Evoke(R) Charger Evoke(R) External Closed-Loop Stimulator Evoke(R) 12C Percutaneous Lead Kit Evoke(R) Patient Controller Evoke(R) Intraoperative Cable Kit Evoke(R) Epidural Needle Evoke(R) 12C Lead Extension Kit Evoke(R) eCLS Battery Charger Kit Evoke(R) Clinical Interface Evoke(R) Closed-Loop Stimulator Evoke(R) Tunneling Tool Evoke(R) Clinical System Transceiver Evoke Epidural Needle, 6.5" Evoke 12C Percutaneous Lead Kit - 90cm Evoke Tunneling Tool Evoke 12C Percutaneous Lead Kit - 60cm Evoke Intraoperative Cable Kit Evoke Spares Kit Evoke 12C Lead Extension Kit - 55cm Evoke Lead Adapter Kit

    Establishment Types

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