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Advanced Silicone Scar Sheet
EUDAMEDClass I (EU MDR)
Ref SS0430Ref SS0515Ref SS02505Ref SS0420
Identity
- Trade Name
- Advanced Silicone Scar Sheet EUDAMED
- Device Name
- Advanced Silicone Scar Sheet EUDAMED
- Model / Reference
- SS0430 EUDAMEDSS0515 EUDAMEDSS02505 EUDAMEDSS0420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06262298000450 EUDAMED06262298000498 EUDAMED06262298000542 EUDAMED06262298000467 EUDAMED
- Basic UDI-DI
- 62622980SS0430FL EUDAMED62622980SS0515FV EUDAMED62622980SS02505EL EUDAMED62622980SS0420FH 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 | 62622980SS0430FL | 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 (4)
- EUDAMED 54f499d2-5d32-40a5-b631-82bbd579bda6 61 fields · synced Jul 19, 2026
- EUDAMED dfaf0a2b-9367-46a5-93d0-a4ca9317bef0 61 fields · synced May 17, 2026
- EUDAMED 25327888-1e9a-4305-bf1d-ef1081a062a6 61 fields · synced May 18, 2026
- EUDAMED 762b6370-c7b1-45a7-b1b3-83ffed849dd6 61 fields · synced May 19, 2026