Identity
- Trade Name
- Advazorb Heel EUDAMEDFDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Advazorb Heel EUDAMEDAbsorbent foam dressing with film backing, 17cm X 21cm. Advazorb Heel is a conformable, non-adherent, absorbent, polyurethane foam dressing with a breathable film backing designed to fit around the heel. A non-adherent foam dressing with excellent fluid handling properties. Ideal for use under compression bandaging with its fluid retention, low profile and low friction film backing. Advazorb Heel also contributes to a pressure relieving protocol when used in conjunction with pressure relieving devices. FDA UDI
- Model / Reference
- CR4228 EUDAMEDCR4502 FDA UDI
- Description
- Absorbent foam dressing with film backing, 17cm X 21cm. Advazorb Heel is a conformable, non-adherent, absorbent, polyurethane foam dressing with a breathable film backing designed to fit around the heel. A non-adherent foam dressing with excellent fluid handling properties. Ideal for use under compression bandaging with its fluid retention, low profile and low friction film backing. Advazorb Heel also contributes to a pressure relieving protocol when used in conjunction with pressure relieving devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031476460 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060031476460 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 — 21 Centimeter FDA UDIWidth — 17 Centimeter FDA UDI
Advazorb Heel 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-05060031476460 | 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 067ead03-831a-4df1-a21a-8d9c21a4a1a4 61 fields · synced Aug 4, 2026
- FDA UDI e23297c1-ea85-4088-b3d6-b8c207db98e2 35 fields · synced May 30, 2026