Identity
- Trade Name
- Vellafilm EUDAMED
- Device Name
- Vellafilm EUDAMED
- Model / Reference
- CR3921 EUDAMEDCR3919 EUDAMEDCR3917 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031472868 EUDAMED05060031472820 EUDAMED05060031472783 EUDAMED
- Basic UDI-DI
- B-05060031472868 EUDAMEDB-05060031472820 EUDAMEDB-05060031472783 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDIreland EUDAMEDPoland 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
Vellafilm by Brightwake Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05060031472868 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brightwake Limited
- EUDAMED SRN
- GB-MF-000012039
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (3)
- EUDAMED 17b4ec6c-5ddb-4391-a10c-3720bea20990 61 fields · synced Jul 14, 2026
- EUDAMED ab634960-86ae-4232-b93b-82c17df2b651 61 fields · synced May 11, 2026
- EUDAMED c4c814f8-adce-4459-8e64-4a9bf68c5684 61 fields · synced May 11, 2026