Identity
- Trade Name
- Advazorb Fixation EUDAMEDFDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Advazorb Fixation EUDAMEDPost-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. FDA UDI
- Model / Reference
- CR4341 EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031479522 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060031479522 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
- Ireland 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 — 12 Centimeter FDA UDIWidth — 10 Centimeter FDA UDI
Advazorb Fixation by Brightwake Limited — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-05060031479522 | 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 a5044a50-29d0-4d11-96ed-a9f7ef64cb7e 61 fields · synced Jul 9, 2026
- FDA UDI 403e021d-aeb4-4b35-aa1b-11a27277ce5a 35 fields · synced May 30, 2026