BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    ACTIS MEDICAL

    Reg #: 3034532468 · FEI: 3034532468 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    ACTIS MEDICAL
    Registration Number
    3034532468
    FEI Number
    3034532468
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 3/18 Ashwin Parade
    City
    Torrensville South Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K260090

    Owner / Operator

    Firm Name
    ACTIS MEDICAL
    Operator Number
    10092149
    Address
    18 Dequetteville Terrace
    City
    Kent Town
    State
    South Australia
    Postal Code
    5067
    Country
    AU

    US Agent

    Business Name
    Aztech Regulatory and Quality LLC
    Contact Name
    Joseph Azary
    Address
    543 Long Hill Ave
    City
    Shelton
    State
    CT
    ZIP
    06484
    Country
    US
    Email
    [email protected]
    Phone
    203 2426670

    Products

    Device Name Product Code
    Probe And Director, Gastro-Urology FGM
    Orthopedic Manual Surgical Instrument LXH
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Passer HWQ
    Bit, Drill HTW

    Proprietary Names

    Surgical Director A3 Access Drill Kit - Manual Orthopedic Instruments Smart Osteotomy Inner Passer Spade Tip Drill / Drill Bit

    Establishment Types

    Manufacture Medical Device