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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Eclypse	CR3808	EUDAMEDFDA UDI	Class IIb	Active
Sofshield Laryngectomy Protector	AS3777	EUDAMED	Class I	Active
Eclypse Adherent	CR3881	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Silfix	CR4178	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Border	CR4296	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Border Lite	CR4201	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Border Oval	CR4299	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Silfix	CR4180	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Non-Backed	CR4519	EUDAMEDFDA UDI	Class IIb	Active
Voice Prosthesis Brushes	CR4508	EUDAMED	Class I	Active
Eclypse	CR4460	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Boot	CR4237	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Border	CR4485	EUDAMEDFDA UDI	Class IIb	Active
Hemosep Cell Concentrator Pack	CR4426	EUDAMED	Class IIb	Active
Advazorb	CR4169	EUDAMEDFDA UDI	Class IIb	Active
Algivon Plus	CR4230	EUDAMED	Class IIb	Active
Tracoe Purofoam-T Small	CR4557	EUDAMED	Class IIb	Active
Eclypse Adherent	CR3863	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Plus T	CR3900	EUDAMED	Class IIb	Active
Silflex	CR3922	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Adherent Sacral	CR3986	EUDAMEDFDA UDI	Class IIb	Active
Algivon	CR3659	EUDAMED	Class IIb	Active
Activon Tube	CR3830	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Boot	CR4014	EUDAMEDFDA UDI	Class IIb	Active
Advazorb	CR4166	EUDAMEDFDA UDI	Class IIb	Active
Eclypse Foot	CR4219	EUDAMEDFDA UDI	Class IIb	Active
Hemosep Intra-Operative Kit	CR4428	EUDAMED	Class IIa	Active
Advasil Conform	CR3832	EUDAMED	Class I	Active
Sofshield Laryngectomy Protector	AS3669	EUDAMED	Class I	Active
Sofshield Laryngectomy Protector	AS3765	EUDAMED	Class I	Active
Advazorb Border Lite	CR4197	EUDAMEDFDA UDI	Class IIb	Active
Silflex	CR3923	EUDAMEDFDA UDI	Class IIb	Active
Advazorb	CR4168	EUDAMEDFDA UDI	Class IIb	Active
Siltape	CR3939	EUDAMEDFDA UDI	Class I	Active
Activon Manuka Honey Barrier Cream 100g	CR4546	EUDAMEDFDA UDI	Class I	Active
Activon Tube	CR4493	EUDAMEDFDA UDI	Class IIb	Active
Advazorb	CR4165	EUDAMEDFDA UDI	Class IIb	Active
Hemosep Intra-Operative Stand	CR4429	EUDAMED	Class I	Active
Tracheostomy Tube Holder Paediatric	CR4510	EUDAMED	Class I	Active
Advazorb Border Lite	CR4200	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Heel	CR4228	EUDAMEDFDA UDI	Class IIb	Active
Wound Probe	CR4236	EUDAMED	Class I	Active
Advazorb	CR4221	EUDAMEDFDA UDI	Class IIb	Active
Hemosep Suction Kit	CR4434	EUDAMED	Class IIa	Active
Eclypse	CR3769	EUDAMEDFDA UDI	Class IIb	Active
Advazorb Border	CR4190	EUDAMEDFDA UDI	Class IIb	Active
Endotracheal Tube Holder	CR4509	EUDAMED	Class I	Active
Activon Tulle	CR3761	EUDAMED	Class IIb	Active
Eclypse	CR3818	EUDAMEDFDA UDI	Class IIb	Active
Advazorb T Lite	CR4212	EUDAMED	Class IIb	Active

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