Identity
- Trade Name
- Advanced Silicone Scar Sheet EUDAMED
- Device Name
- Advanced Silicone Scar Sheet EUDAMED
- Model / Reference
- SS0307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06262298000535 EUDAMED
- Basic UDI-DI
- 62622980SS0307FL EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
Advanced Silicone Scar Sheet by Dadeh Gostaran Dena — 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 | 62622980SS0307FL | Class I | Active |
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Manufacturer
- Manufacturer
- Dadeh Gostaran Dena
- EUDAMED SRN
- IR-MF-000038532
- Authorised Representative
- Eska Diagnostics Kft HU-AR-000037211
Sources (1)
- EUDAMED ee0204fd-28d0-4416-9b40-9a64bf8a3b1c 61 fields · synced Jun 18, 2026