Identity
- Trade Name
- Advazorb Sacral EUDAMED
- Device Name
- Advazorb Sacral EUDAMED
- Model / Reference
- CR4401 EUDAMEDCR4402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031479836 EUDAMED05060031479874 EUDAMED
- Basic UDI-DI
- B-05060031479836 EUDAMEDB-05060031479874 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Advazorb Sacral by Brightwake Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060031479836 | Class IIb | Active |
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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 de93a8cb-d639-4221-94e7-c531d2b2a3a1 61 fields · synced Aug 4, 2026
- EUDAMED 4d0e1d18-0045-4740-816d-5051cb3ad8a9 61 fields · synced May 18, 2026