BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    Axis

    Reg #: 3003898943 · FEI: 3003898943 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SOUTHERN MEDICAL (PTY) LTD
    Registration Number
    3003898943
    FEI Number
    3003898943
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    55 Regency, Route 21 Corporate Park, Irene, Pretoria
    City
    IRENE Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K231145

    Owner / Operator

    Firm Name
    Southern Medical (Pty) Ltd
    Operator Number
    9052759
    Address
    55 Regency, Route 21 Corporate Park, Irene, --
    City
    Pretoria
    State
    Gauteng
    Postal Code
    0062
    Country
    ZA
    Correspondent
    Dalene - Styger

    US Agent

    Business Name
    Southern Implants North America Inc.
    Contact Name
    David Luiz
    Address
    225 Chimney Corner Lane, Suite 3011
    City
    Jupiter
    State
    FL
    ZIP
    33458
    Country
    US
    Email
    [email protected]
    Phone
    561 4720990 ext. 0

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    Axis

    Establishment Types

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