Data / Medical devices / United Kingdom / Brightwake Ltd
Brightwake Ltd: FDA-registered device maker in Kirkby-in-Ashfield Nottinghamshire, United Kingdom, 2 510(k) clearances
Brightwake Ltd is registered with the FDA (registration 3007648359) in Kirkby-in-Ashfield Nottinghamshire, United Kingdom. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 26, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007648359
- Address
- Lowmoor Business Park, Kirkby-in-Ashfield Nottinghamshire, United Kingdom, NG17 7JZ
- Owner or operator
- Brightwake Ltd (10029414)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 19, 2010
- Registered through
- 2026
- Brand names listed
- AQUACEL Ag Burn, AVELLE Negative Pressure Wound Therapy System, Activon Manuka Honey Barrier Cream, Activon Tube 100 percent Medical Grade Manuka Honey with No Preservatives, Activon Tulle, Advasil Conform Silicone gel sheet, Advazorb Areola, Advazorb Border Hydrophilic Foam Dressing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Manufacturer | accessdata.fda.gov |
| Brush, Cleaning, Tracheal Tube | EPE | 1 | Manufacturer | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2011 | K101114 | ADVANCIS ACTIVON TUBE | FRO | Substantially Equivalent | Advancis Medical | accessdata.fda.gov |
| December 15, 2010 | K101118 | ACTIVON TULLE | FRO | Substantially Equivalent | Calidad Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Tape And Bandage, Adhesive
- All makers of Bandage, Liquid, Skin Protectant
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Dressing, Wound, Hydrophilic
- All makers of Tape, Measuring, Rulers And Calipers
Updated July 26, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.