Identity
- Trade Name
- Silflex EUDAMEDFDA UDI
- Generic Name
- Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI
- Device Name
- Silflex EUDAMEDSoft silicone wound contact layer 12 cm X 15 cm. A wound contact layer made from polyester mesh and coated with Silfix soft silicone. Silflex is designed to gently adhere to the skin surrounding a wound and not to the wound bed. This is an atraumatic dressing designed to minimise the pain and trauma associated with dressing change. The dressing’s large perforations allow for the passage of exudate and irrigation of wound. FDA UDI
- Model / Reference
- CR3924 EUDAMEDFDA UDI
- Description
- Soft silicone wound contact layer 12 cm X 15 cm. A wound contact layer made from polyester mesh and coated with Silfix soft silicone. Silflex is designed to gently adhere to the skin surrounding a wound and not to the wound bed. This is an atraumatic dressing designed to minimise the pain and trauma associated with dressing change. The dressing’s large perforations allow for the passage of exudate and irrigation of wound. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031472981 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060031472981 EUDAMED
- FDA Product Code
- NAD FDA UDI
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4020 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 — 15 Centimeter FDA UDIWidth — 12 Centimeter FDA UDI
Silflex 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-05060031472981 | 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 5815e2a1-54a9-49bd-be0f-dfc2cd1780e7 61 fields · synced Jun 18, 2026
- FDA UDI 9441e4aa-426c-4a75-98cd-9ffe30fbc3b8 35 fields · synced May 30, 2026