BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter

    Reg #: 3021230784 · FEI: 3021230784 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DISA MEDINOTEC (PTY) LTD
    Registration Number
    3021230784
    FEI Number
    3021230784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Stand 171, Northlands Business Park, Bush Telegraph Street,
    City
    Northriding, Johannesburg Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K241562

    Owner / Operator

    Firm Name
    DISA Medinotec (Pty) Ltd
    Operator Number
    10083849
    Address
    Stand 171, Northlands Business Park, Bush Telegraph Street,
    City
    Northriding, Johannesburg
    State
    Gauteng
    Postal Code
    2169
    Country
    ZA
    Correspondent
    Lyndon Oldfield

    US Agent

    Business Name
    Biologics Consulting
    Contact Name
    MARGARET VERNON
    Address
    100 DAINGERFIELD ROAD, SUITE 400
    City
    Alexandria
    State
    VA
    ZIP
    22314
    Country
    US
    Email
    [email protected]
    Phone
    720 8833633

    Products

    Device Name Product Code
    Balloon Aortic Valvuloplasty OZT

    Proprietary Names

    OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter

    Establishment Types

    Manufacture Medical Device