BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD

    Reg #: 3010370269 · FEI: 3010370269 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD
    Registration Number
    3010370269
    FEI Number
    3010370269
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    313 Chris Barnard Building UCT Medical School, Anzio Road, Observatory
    City
    Cape Town Western Cape
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K243184

    Owner / Operator

    Firm Name
    Strait Access Technologies Holdings (Pty) Ltd
    Operator Number
    10094135
    Address
    313 Chris Barnard Building UCT Medical School, Anzio Road, Observatory
    City
    Cape Town
    State
    Western Cape
    Postal Code
    7925
    Country
    ZA
    Correspondent
    Veruscha Goodheart

    US Agent

    Business Name
    DAWA Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    305 5999773 ext. 9373

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

    CenterFlow Molding Balloon Catheter

    Establishment Types

    Manufacture Medical Device