Identity
- Trade Name
- ENA SHINY Compl. finishing kit EUDAMED
- Device Name
- SHINY EUDAMED
- Model / Reference
- SHINY EUDAMEDESKIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICESKIT1 EUDAMED
- Basic UDI-DI
- ++EMICFAM5AKVX EUDAMED
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Finishing and polishing, direct or indirect, composite dental restorations EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
ENA SHINY Compl. finishing kit by Micerium S.p.A. — 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 | ++EMICFAM5AKVX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-PR-000025624
Sources (1)
- EUDAMED e2b063c0-640c-4f24-a64e-342bd7a6761f 61 fields · synced Jul 19, 2026