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Activon Manuka Honey Barrier Cream

EUDAMEDFDA UDI

Class I (EU MDR)

Ref CR4552Model CR4546

by Brightwake Limited

Identity

Trade Name
Activon Manuka Honey Barrier Cream EUDAMEDFDA UDI
Generic Name
Dry skin moisture barrier dressing FDA UDI
Device Name
Activon Manuka Honey Barrier Cream 100g EUDAMED
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. FDA UDI
Model / Reference
CR4546 EUDAMED
CR4552 EUDAMEDFDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
05060031485356 EUDAMED
05060031485349 FDA UDI
Basic UDI-DI
506003148ActivonBarrierLV EUDAMED
FDA Product Code
NEC FDA UDI
EMDN Code
M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
GMDN Term
Dry skin moisture barrier dressing FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
880.5090 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 10 Gram FDA UDI

Activon Manuka Honey Barrier Cream by Brightwake Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brightwake Limited
EUDAMED SRN
GB-MF-000012039
Authorised Representative
CS Life Sciences Europe Ltd IE-AR-000004113

Sources (2)

  • EUDAMED 0840531f-3962-4294-8d31-5029d1df3d4b 61 fields · synced Jul 26, 2026
  • FDA UDI 35d9da47-6f84-4c26-9870-d0fb8035e2bd 35 fields · synced May 30, 2026