BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    AMG MEDICAL INC.

    Reg #: 8022077 · FEI: 3000171642 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    74
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    AMG MEDICAL INC.
    Registration Number
    8022077
    FEI Number
    3000171642
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8505 DALTON
    City
    MONTREAL Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K130231

    Owner / Operator

    Firm Name
    AMG MEDICAL INC.
    Operator Number
    8022077
    Address
    8505 DALTON, --
    City
    MONTREAL
    State
    Quebec
    Postal Code
    H4T 1V5
    Country
    CA

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    KEVIN WALLS
    Address
    33 Golden Eagle Ln
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Stand, Infusion FOX
    Adaptor, Hygiene ILS
    Adult Portable Bed Rails For Medical Purposes QTC
    Exerciser, Non-Measuring ION
    Bedding, Disposable, Medical KME
    Nebulizer (Direct Patient Interface) CAF
    Urinal FNP
    Pack, Hot Or Cold, Reusable IME
    Scale, Patient FRW
    Electrode, Cutaneous GXY
    Garment, Protective, For Incontinence EYQ
    Stethoscope, Manual LDE
    Attachment, Commode, Wheelchair INB
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Basin, Emesis FNY
    Bedpan FOB

    Proprietary Names

    Physio Logic ProScan Non-Contact Infrared Thermometer Physiologic Non-contact Infrared Thermometer Physio Logic Essentia+ BPM (106-930) MedPro Heavy Duty SS IV Pole MedPro Stackable SS IV Pole MedPro Euro Commode MedPro Home Care Commode MedPro Standard Commode MedPro Folding Commode MedPro MGrip Contoured Bedside Rail MedPro Bed Side Rail ProActive Pedal Exerciser Ultra-Blok Underpads 23x36" Ultra-Blok Underpads 17x24" MEDPRO COMPRESSOR NEBULIZER MedPro Bulbous Urinal MedPro Urine Specimen Bowl MedPro Specimen Cup MedPro Graduated Jug MedPro Female Urinal MedPro Male Urinal ProActive ThermOBeads Multiuse Compress ProActive ThermOBeads Back Wrap ProActive ThermOBeads Eye Mask ProActive ThermOBeads Shoulder and Neck ProActive ThermOBeads Knee Wrap ProActive Therm-O-Clay Multi-Purpose Pack MedPro Versa Hot / Cold Pack (740-785) Therm-O-Clay Waterless Cozy Bottle Therm-O-Clay Luxurious Eye Mask PhysioLogic DigiSlim Scale MEDPRO UNDERPAD WHITE AMG PROTECTIVE UNDERWEAR MEDPRO INCONTINENT UNDERPADS AMG Ultra-Absorbent Protective Underwear UltraBlok Quilted Underpad Ultra-Blok Underpad ColorPro Steth Silver Premier Elite 2H Steth ColorPro Sprague-Rappaport Steth ColorPro Dual Steth Silver MedPro DEFENCE - ZORB Commode Liners Standard Commode by AMG Medical Inc. ProActive Alevia 2 in 1 TENS Proactive Elle TENS (715-432) ACCUFLEXPRO+ RECTAL THERMOMETER (RED) ACCUFLEXPRO+ ORAL THERMOMETER (BLUE) DigiPro Digital Clinical thermometer (016-625) Physio Logic Accuflex5 VU Thermometer (016-651) DigiPro Oral Thermometer - Blue (016-618) DigiPro Oral Thermometer - Red (016-619) PhysioLogic Accuflex Thermometer - Red (016-629) PhysioLogic Accuflex Thermometer - Blue (016-628) Physio Logic Digiflex 10 Thermometer (016-645) Physio Logic Digital 10 Thermometer (016-644) Physiologic Accuflex Pro+ Digital Thermometer MedPro Kidney Dish - Emesis MedPro Disposable Wash Basin MedPro General Purpose Bowl MedPro Large Bowl MedPro Lid for Large Bowl MedPro Small Bowl MedPro Vomit Bag MedPro Defense Zorbi Vomit Bag MedPro Disposable Bedpan Liner MedPro Lid for Fracture Bedpan MedPro Fracture BedPan Support MedPro Lid for Bedpan Liner MedPro Plastic Standard bedpan support for pulp disposables MedPro - ZORBI Biodegradable Bedpan Liners MedPro Plastic Fracture bedpan support for pulp disposables MedPro Plastic BedPan MedPro Defense Disposable Pulp Bedpan Liner MedPro Fracture BedPan

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device