BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SOUTHMEDIC, INC.

    Reg #: 8022032 · FEI: 3001717360 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    50
    Establishment Types
    6
    Classifications
    27

    Registration Details

    Registration Name
    SOUTHMEDIC, INC.
    Registration Number
    8022032
    FEI Number
    3001717360
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50 ALLIANCE BLVD.,
    City
    BARRIE Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K971229

    Owner / Operator

    Firm Name
    SOUTHMEDIC, INC.
    Operator Number
    8022032
    Address
    50 ALLIANCE BLVD.,, --
    City
    BARRIE
    State
    Ontario
    Postal Code
    L4M 5K3
    Country
    CA
    Correspondent
    Christine Puddicombe

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Instrument, Manual, Surgical, General Use MDM
    Device, Specimen Collection LIO
    Dna Specimen Collection, Saliva OYJ
    Accessories, Cleaning Brushes, For Endoscope MNL
    Cup, Menstrual HHE
    Handle, Scalpel GDZ
    Research Use Only/Clinical Chemistry Devices OTV
    Research Use Only/Microbiology OTT
    Laryngoscope, Rigid CCW
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Support, Patient Position CCX
    Blade, Scalpel GES
    Mask, Oxygen BYG
    Retainer, Surgical GCZ
    Apparatus, Autotransfusion CAC
    Brush, Scrub, Operating-Room GEC
    Topical Approximation System MZR
    Endoscopic Bite Block MNK
    Nebulizer (Direct Patient Interface) CAF
    Ligator, Hemorrhoidal FHN
    Retention Device, Suture KGS
    General Surgery Tray LRO
    Cannula, Nasal, Oxygen CAT
    Cleaner, Ultrasonic, Medical Instrument FLG
    Stylet, Tracheal Tube BSR
    Vaporizer, Anesthesia, Non-Heated CAD

    Proprietary Names

    Cannulator ABRA Loop Cannulator Scope Sweeper Dual Action Endoscope Cleaning Brushes Flex Disc, Flex Cup, Flex Reusable Menstrual Disc, Softdisc, Flex Plant+ Menstrual Disc Southmedic Scalpel Handle BetterShield Clear Choice Eye and Face Shields and Frames Capnoxygen Mask Foam Headrest Lancet Southmedic Blades and Scalpels OxyArm OxyMulti Mask OxyMask Ultra OxyTrach Oxy Aerosol Mask OxyMask OxyKid OxyPlus OxyTyke Oxy2Mask Southmedic Surgical Retainer ProCell Surgical Sponge-Blood Recovery Unit Oxy2Mask EtCO2 Oxy2Pro Southmedic Instrument Cleaning Brushes DynaCleft Nasal Elevator DynaCleft Bite Block Multi Dose Inhaler Adapter CRH O'Regan Hemorrhoid Ligator with Integrated Obturator OxyMask Adult Nebulizer Kit OxyPlus Nebulizer Kit ABRA DTS Button Tails ABRA DTS Elastomer Retainer ABRA DTS Silicone Elastomer Cord ABRA Abdominal 3 Row Pack ABRA Abdominal Closure ABRA Surgical Skin Closure ABRA Adhesive Skin Closure OxyArm Nasal Cannula EcoBase EcoZyme Ultra, EcoZyme Ultra Spray, EcoZyme Auto EcoZyme Foam Spray EcoZyme Foam EcoSonic Descaler Ecozyme-Enzymatic Sponge CO2/O2 Sampling line CO2/O2 Nasal Cannula Quik Fil Vapofil AntiSpil

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Foreign Private Label Distributor Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility