Brightwake Limited
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED SRN GB-MF-000012039
- Devices
- 144
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- CS Life Sciences Europe LtdIE
What Brightwake Limited makes
BrightWake Limited manufactures wound care dressings, including nonadherent and permeable types for pressure injury and sacral site management, as well as hydrophilic-gel exudate-absorbent dressings. Their portfolio includes products designed to manage moderate to high exudate without antimicrobial properties, alongside antimicrobial-permeable dressings for infected or high-risk wounds. Examples include contoured and border-adapted dressings for specific anatomical areas, as well as lightweight and sacral-specific variants for patient comfort and adherence.
The company’s devices are classified under EU Medical Device Regulations as Class I, IIa, IIb, III, and unclassified (U), with corresponding FDA UDI listings. Their products are registered in the EU’s EUDAMED database and the FDA’s UDI system, reflecting compliance with both European and US regulatory frameworks. BrightWake Limited operates from the United Kingdom.
Catalogue
Search and filter all 144 devicesShowing 1-50 of 144
Company details
- EUDAMED SRN
- GB-MF-000012039
- DUNS number
- 226502201
- EU VAT number
- 309 3579 42
- EUDAMED status
- Active
- EUDAMED registered name
- Brightwake Limited
- Registered address
- Lowmoor Business Park, NG17 7JZ, Kirkby in Ashfield, United Kingdom (ex Northern Ireland)
- Website
- www.advancis.co.uk
- ra@brightwake.co.uk
- Phone
- +44 (0)1623 751 500
- PRRC contact
- Reece Sims
Frequently asked questions
How many devices does BRIGHTWAKE LIMITED have in the registry?
The registry currently lists 144 devices for BRIGHTWAKE LIMITED. Devices recorded under merged duplicate company entries are counted once.
Which registries list BRIGHTWAKE LIMITED's devices?
Among its 50 most recently registered devices, BRIGHTWAKE LIMITED has devices listed in EUDAMED (31 devices) and FDA GUDID (42 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BRIGHTWAKE LIMITED's devices fall under?
Among its 50 most recently registered devices, the classes recorded for BRIGHTWAKE LIMITED's devices are Class I and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from BRIGHTWAKE LIMITED in the registry?
The most recently registered devices listed for BRIGHTWAKE LIMITED include Eclypse Non-Backed, Eclypse CR4503, Advazorb Silfix Lite CR4204 and Advazorb Sacral CR4501.