Identity
- Trade Name
- Silben Nano Repair Spray EUDAMED
- Device Name
- Healing Spray EUDAMED
- Model / Reference
- SLBVN125E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990632497 EUDAMED
- Basic UDI-DI
- 805299063DERMA002UE EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia 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
Silben Nano Repair Spray by Nirial Pharma srl — Class IIa — 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 | 805299063DERMA002UE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nirial Pharma srl
- EUDAMED SRN
- IT-MF-000018760
Sources (1)
- EUDAMED fc398aca-a625-499c-95d0-d35553886fb3 61 fields · synced Oct 6, 2026