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Advazorb Border

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref CR4191

by Brightwake Limited

Identity

Trade Name
Advazorb Border EUDAMEDFDA UDI
Generic Name
Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Device Name
Advazorb Border EUDAMED
Absorbent foam dressing with soft silicone wound contact layer and border, 10cm 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. FDA UDI
Model / Reference
CR4191 EUDAMEDFDA UDI
Description
Absorbent foam dressing with soft silicone wound contact layer and border, 10cm 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. FDA UDI

Identifiers

Primary DI / UDI-DI
05060031475548 EUDAMEDFDA UDI
Basic UDI-DI
B-05060031475548 EUDAMED
FDA Product Code
NAC FDA UDI
EMDN Code
M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
GMDN Term
Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class I FDA UDI
Regulation Number
878.4018 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

Dimensions & Sizes

Size
Length — 10 Centimeter FDA UDI
Width — 10 Centimeter FDA UDI

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

Advazorb Border by Brightwake Limited — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

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 b6b17137-ca35-4943-8372-fd633ef4d11b 61 fields · synced Jun 18, 2026
  • FDA UDI 23725c08-4934-4170-8d83-6f9368b85283 35 fields · synced May 30, 2026