BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    BRIGHTWAKE LTD

    Reg #: 3007648359 · FEI: 3007648359 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    59
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    BRIGHTWAKE LTD
    Registration Number
    3007648359
    FEI Number
    3007648359
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lowmoor Business Park
    City
    Kirkby-in-Ashfield Nottinghamshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K101114

    Owner / Operator

    Firm Name
    Brightwake Ltd
    Operator Number
    10029414
    Address
    Sidings Road, Lowmoor Business Park
    City
    Nottingham
    State
    Nottinghamshire
    Postal Code
    NG17 7JZ
    Country
    GB
    Correspondent
    Edwin Lindsay

    US Agent

    Business Name
    Medi USA LP
    Contact Name
    John Cody
    Address
    6481 Franz Werner Parkway
    City
    Whitsett
    State
    NC
    ZIP
    27377
    Country
    US
    Email
    [email protected]
    Phone
    336 4494440 ext. 211

    Products

    Device Name Product Code
    Support, Breathing Tube JAY
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Dressing, Wound, Hydrophilic NAC
    Brush, Cleaning, Tracheal Tube EPE
    Dressing, Wound, Occlusive NAD
    Dressing, Wound, Drug FRO
    Tape And Bandage, Adhesive KGX
    Elastomer, Silicone, For Scar Management MDA
    Bandage, Elastic FQM
    Bandage, Liquid, Skin Protectant NEC
    Device, Fixation, Tracheal Tube CBH
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Tape, Measuring, Rulers And Calipers FTY

    Proprietary Names

    Tracheostomy Tube Holder with brush AVELLE Negative Pressure Wound Therapy System Tracoe Purofoam-T Lite Eclypse Super Absorbent Dressing Advazorb Hydrophilic Foam Dressing Eclypse Border Eclypse Sacral Adherent Super Absorbent Dressing Eclypse Border Oval Adherent Super Absorbent Dressing Advazorb Sacral Hydrophilic Foam Dressing Eclypse Adherent Sacral Super Absorbent Dressing Eclypse Adherent Super Absorbent Dressing Advazorb Silfix Hydrophilic Foam Dressing Advazorb Silfix Lite Hydrophilic Foam Dressing Advazorb Border Lite Hydrophilic Foam Dressing Eclypse Boot Super Absorbent Dressing Advazorb Lite Hydrophilic Foam Dressing Advazorb Heel Hydrophilic Foam Dressing Eclypse Foot Super Absorbent Dressing Advazorb Border Hydrophilic Foam Dressing Eclypse Contour Super Absorbent Dressing Advazorb Fixation Advazorb Areola Tracoe Purofoam-T Small Post-Decannulation Dressing Eclypse Non-Backed Tracoe Purofoam-T Large Voice Prosthesis Brush Silflex soft silicone wound contact dressing Vellafilm soft silicone wound contact dressing Activon Tube 100 percent Medical Grade Manuka Honey with No Preservatives Siltape Soft silicone perforated tape Advasil Conform Silicone gel sheet Surepress Unna-Flex Elastic Unna boot Unna boot Stretch Zinc 4” x 10yrd Unna boot Stretch Zinc + Calamine 3” x 10yrd Unna boot Non-stretch Zinc + Calamine 3” x 10yrd Unna boot Non-stretch Zinc 4” x 10yrd Unna-Z Stretch Zinc + Calamine 3” x 10yrd Unna boot Stretch Zinc 3” x 10yrd Unna-Z Non-stretch Zinc 4” x 10yrd Unna-Z Stretch Zinc 4” x 10yrd Unna-Z Non-stretch Zinc 3” x 10yrd Unna-Z Non-stretch Zinc + Calamine 4” x 10yrd Unna boot Non-stretch Zinc + Calamine 4” x 10yrd Unna-Z Stretch Zinc + Calamine 4” x 10yrd Unna boot Stretch Zinc + Calamine 4” x 10yrd Unna-Z Stretch Zinc 3” x 10yrd Unna boot Non-stretch Zinc 3” x 10yrd Unna-Z Non-stretch Zinc + Calamine 3” x 10yrd Activon Manuka Honey Barrier Cream AQUACEL Ag Burn Activon Tulle Tracheostomy Tube Holder Endotracheal Tube Holder Sofshield Laryngectomy Protector Sofnex Laryngectomy Protector Cascade Shower Protector Wound Probe

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)