Identity
- Trade Name
- Advasil Conform EUDAMED
- Device Name
- Advasil Conform EUDAMED
- Model / Reference
- CR3845 EUDAMEDCR3832 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031471946 EUDAMED05060031471380 EUDAMED
- Basic UDI-DI
- 506003147AdvasilConfNon6H EUDAMED
- EMDN Code
- M04010203 FIXATION SILICONE DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Advasil Conform by Brightwake Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506003147AdvasilConfNon6H | Class I | 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 800f6335-2672-41d9-acdb-5a5f55465642 61 fields · synced Jul 12, 2026
- EUDAMED 2915102a-7f08-41cf-974e-d9dd8221a82e 61 fields · synced May 19, 2026