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Silconex Scar Treatment Gel
EUDAMEDClass I (EU MDR)
Ref SILCONEX6GMARModel 15g EN/FRRef SILCONEX15GMAR
Identity
- Trade Name
- Silconex Scar Treatment Gel EUDAMED
- Device Name
- Silconex Scar Treatment Gel EUDAMED
- Model / Reference
- 15g EN/FR EUDAMEDSILCONEX6GMAR EUDAMEDSILCONEX15GMAR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056682200042 EUDAMED05056682200110 EUDAMED
- Basic UDI-DI
- 505668220ScartreatmentN2 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Silconex Scar Treatment Gel by Ennogen Healthcare International 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 | 505668220ScartreatmentN2 | Class I | Active |
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Manufacturer
- Manufacturer
- Ennogen Healthcare International Limited
- EUDAMED SRN
- UK-MF-000039877
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (2)
- EUDAMED 58e6c780-ec04-4e52-a03e-5c73b390888f 61 fields · synced Oct 6, 2026
- EUDAMED 81f90084-38ab-4910-b6ac-6660986b8d06 61 fields · synced May 18, 2026