Identity
- Trade Name
- Advazorb Silfix EUDAMEDFDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Advazorb Silfix EUDAMEDHydrophilic foam dressing with soft silicone wound contact layer, 10cm x 20cm. Advazorb Silfix is a self adherent absorbent dressing with a Silfix® soft silicone wound contact layer. 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 and provides gentle release. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The backing is breathable, prevents strike through and protects the wound. FDA UDI
- Model / Reference
- CR4181 EUDAMEDFDA UDI
- Description
- Hydrophilic foam dressing with soft silicone wound contact layer, 10cm x 20cm. Advazorb Silfix is a self adherent absorbent dressing with a Silfix® soft silicone wound contact layer. 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 and provides gentle release. This is an atraumatic dressing which means it is designed to minimise the pain and trauma associated with dressing change. The backing is breathable, prevents strike through and protects the wound. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031475142 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060031475142 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 EUDAMEDClass 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 UDIWidth — 20 Centimeter FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Advazorb Silfix by Brightwake Limited — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060031475142 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 7641ee44-ba6c-4af1-9638-b980ebe8b17c 61 fields · synced Jul 15, 2026
- FDA UDI 197d4a4f-47a7-4fba-8ba1-25fcc3fbea45 35 fields · synced May 30, 2026