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BRIGHTWAKE LIMITED

United Kingdom (ex Northern Ireland)·GB-MF-000012039

Last updated May 27, 2026

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United Kingdom (ex Northern Ireland)
Address: Lowmoor Business Park, Kirkby in Ashfield, United Kingdom (ex Northern Ireland)
Website: www.advancis.co.uk
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +44 (0)1623 751 500
PRRC Contact: Marta Maj
EUDAMED SRN: GB-MF-000012039
FDA FEI Number: —
DUNS Number: 226502201

Catalogue (130)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Algivon Plus Ribbon	CR4441	EUDAMED	Class IIb	Active
Tracheostomy Neck Band	507906-000000	EUDAMED	Class I	Active
Eclypse Adherent Sacral	CR3985	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Border	CR4196	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Border Lite	CR4202	EUDAMEDFDA UDI	Class IIb	Active
Spare Endotracheal Neck Band	CR4513	EUDAMED	Class I	Active
Tracoe Purofoam-T Large	CR4555	EUDAMED	Class IIb	Active
Sofshield Laryngectomy Protector	AS3764	EUDAMED	Class I	Active
Sofshield Laryngectomy Protector	AS4056	EUDAMED	Class I	Active
Advazorb Sacral	CR4401	EUDAMED	Class IIb	Active
Insil	CR3942	EUDAMED	Class I	Active
Advazorb Border Lite	CR4203	EUDAMEDFDA UDI	Class IIb	Active
Tracheostomy Cleaning Swabs 9mm	CR4560	EUDAMED	Class I	Active
Eclypse Adherent	CR3883	EUDAMEDFDA UDI	Class IIb	Active
Actilite	CR3852	EUDAMED	Class IIb	Active
Algivon	CR3831	EUDAMED	Class IIb	Active
Tracheostomy Cleaning Swabs 12 mm	CR4559	EUDAMED	Class I	Active
Physiotulle Ag	CR4494	EUDAMED	Class III	Active
Eclypse Border Oval	CR4300	EUDAMEDFDA UDI	Class IIb	Active
Physiotulle Ag	CR4495	EUDAMED	Class III	Active
Cascade Shower Protector	AS3835	EUDAMED	Class I	Active
Advazorb Silfix	CR4182	EUDAMEDFDA UDI	Class IIb	Active
Eclypse	CR4439	EUDAMEDFDA UDI	Class IIb	Active
Advazorb	CR4170	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Non-Backed	CR4517	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Silfix	CR4179	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Border	CR4487	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Border	CR4194	EUDAMEDFDA UDI	Class IIb	Active
Vellafilm	CR3921	EUDAMED	Class IIb	Active
Advazorb Border	CR4192	EUDAMEDFDA UDI	Class IIb	Active

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