BRIGHTWAKE LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30076483593007648359BRIGHTWAKE LTD1N2026-01-01Lowmoor Business Park Kirkby-in-Ashfield Nottinghamshire GB NG17 7JZ

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05060031482652Eclypse Non-Backed - Eclypse Non-backed is an exudate management wound dressing. The dressing combines a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate and a sub-backing layer for even exudate distribution.+441623751500info@advancis.co.uk
05060031482690Eclypse Non-Backed - Eclypse Non-backed is an exudate management wound dressing. The dressing combines a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate and a sub-backing layer for even exudate distribution.+441623751500info@advancis.co.uk
05060031482737Eclypse Non-Backed - Eclypse Non-backed is an exudate management wound dressing. The dressing combines a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate and a sub-backing layer for even exudate distribution.+441623751500info@advancis.co.uk
05060031484748Activon Manuka Honey Barrier Cream - Activon Manuka Honey Barrier Cream is designed to act as an effective moisture barrier to aid in the prevention of Moisture-Associated Skin Damage (MASD), whilst also acting as a balm to moisturise skin and help reduce existing skin damage and irritation. • Effective moisture barrier against bodily fluids and excretions. • Contains Medical Grade Manuka Honey which assists in the prevention and treatment of infected/Inflamed skin and promotes healing. • Contains Cocoa Butter to help moisturisation of the skin and aids in the prevention of Moisture Associated Skin Damage. • Breathable to assist in the prevention of skin maceration. • Dries quickly. • Contains 99% natural ingredients. Does not contain fragrance, parabens or phthalates. • Washes out of clothing and bedding. Does not stain cotton, nylon or polypropylene.+441623751500info@advancis.co.uk

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1037901034111450K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentFRO2016-07-01
1037901757533140K101118ACTIVON TULLEFRO2010-12-15
1037901280033516K101114ADVANCIS ACTIVON TUBEFRO2011-07-26
1037901117202247
1037901185013613
1037901339231013
1037901516110275
1037901819625621
1037901885260652
1037901943595836
1037901131234276
1037901152830105
1037901185801976
1037901270061520
1037901381626013
1037901397997557
1037901509269336
1037901704669667
1037902042368446

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO32016-07-01

GUDID#

Activon Manuka Honey Barrier Cream - Activon Manuka Honey Barrier Cream is designed to act as an effective moisture barrier to aid in the prevention of Moisture-Associated Skin Damage (MASD), whilst also acting as a balm to moisturise skin and help reduce existing skin damage and irritation.• Effective moisture barrier against bodily fluids and excretions.• Contains Medical Grade Manuka Honey which assists in the prevention and treatment of infected/Inflamed skin and promotes healing.• Contains Cocoa Butter to help moisturisation of the skin and aids in the prevention of Moisture Associated Skin Damage.• Breathable to assist in the prevention of skin maceration.• Dries quickly.• Contains 99% natural ingredients. Does not contain fragrance, parabens or phthalates.• Washes out of clothing and bedding. Does not stain cotton, nylon or polypropylene.

BRIGHTWAKE LIMITED

2025-08-07

Activon Manuka Honey Barrier Cream - Activon Manuka Honey Barrier Cream is designed to act as an effective moisture barrier to aid in the prevention of Moisture-Associated Skin Damage (MASD), whilst also acting as a balm to moisturise skin and help reduce existing skin damage and irritation. • Effective moisture barrier against bodily fluids and excretions. • Contains Medical Grade Manuka Honey which assists in the prevention and treatment of infected/Inflamed skin and promotes healing. • Contains Cocoa Butter to help moisturisation of the skin and aids in the prevention of Moisture Associated Skin Damage. • Breathable to assist in the prevention of skin maceration. • Dries quickly. • Contains 99% natural ingredients. Does not contain fragrance, parabens or phthalates. • Washes out of clothing and bedding. Does not stain cotton, nylon or polypropylene.

BRIGHTWAKE LIMITED

2025-08-07

Activon Manuka Honey Barrier Cream - Activon Manuka Honey Barrier Cream is designed to act as an effective moisture barrier to aid in the prevention of Moisture-Associated Skin Damage (MASD), whilst also acting as a balm to moisturise skin and help reduce existing skin damage and irritation.• Effective moisture barrier against bodily fluids and excretions.• Contains Medical Grade Manuka Honey which assists in the prevention and treatment of infected/Inflamed skin and promotes healing.• Contains Cocoa Butter to help moisturisation of the skin and aids in the prevention of Moisture Associated Skin Damage.• Breathable to assist in the prevention of skin maceration.• Dries quickly.• Contains 99% natural ingredients. Does not contain fragrance, parabens or phthalates.• Washes out of clothing and bedding. Does not stain cotton, nylon or polypropylene.

BRIGHTWAKE LIMITED

2025-08-07

Advazorb Border - Absorbent foam dressing with soft silicone wound contact layer and border, 20 cm X 20 cm. A self adherent absorbent dressing with a Silfix soft silicone wound contact layer and border. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The film backing is breathable and prevents strike through.

BRIGHTWAKE LIMITED

2024-01-17

Advazorb Border - Absorbent foam dressing with soft silicone wound contact layer and border, 20 cm X 20 cm. A self adherent absorbent dressing with a Silfix soft silicone wound contact layer and border. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The film backing is breathable and prevents strike through.

BRIGHTWAKE LIMITED

2024-01-17

Advazorb Border - Absorbent foam dressing with soft silicone wound contact layer and border, 6cm X 12cm. A self adherent absorbent dressing with a Silfix soft silicone wound contact layer and border. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The film backing is breathable and prevents strike through.

BRIGHTWAKE LIMITED

2023-07-27

Advazorb Border - Absorbent foam dressing with soft silicone wound contact layer and border, 7.5cm X 8.5cm. A self adherent absorbent dressing with a Silfix soft silicone wound contact layer and border. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The film backing is breathable and prevents strike through.

BRIGHTWAKE LIMITED

2023-07-27

Advazorb Border - Absorbent foam dressing with soft silicone wound contact layer and border, 5cm X 10cm. A self adherent absorbent dressing with a Silfix soft silicone wound contact layer and border. The dressing has a hydrophilic foam absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The film backing is breathable and prevents strike through.

BRIGHTWAKE LIMITED

2023-07-27

Advazorb Areola - Absorbent foam dressing with soft silicone wound contact layer and border, 13cm x 13cm. A self adherent absorbent dressing with a Silfix® soft silicone wound contact layer and border. The dressing has an absorbent foam pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The film backing is breathable and prevents strike through.

BRIGHTWAKE LIMITED

2023-07-27

Advazorb Fixation - Post-Decannulation Tracheostomy Dressing 12cm X 10cm. A self-adherent absorbent dressing with a Silfix soft silicone wound contact layer and border with a PVC button. The dressing has an absorbent pad with high fluid handling capability. The soft silicone will adhere to surrounding dry skin but not to a wet wound. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The film backing is breathable and prevents strike through.

BRIGHTWAKE LIMITED

2023-07-27

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