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EHSA - ENA Shiny Kit with bond (SE+SHINY)
EUDAMEDClass IIa (EU MDR)
Ref EHSAModel Shiny Kit with bond&etch
Identity
- Trade Name
- EHSA - ENA Shiny Kit with bond (SE+SHINY) EUDAMED
- Device Name
- Shiny Kit with bond&etch EUDAMED
- Model / Reference
- Shiny Kit with bond&etch EUDAMEDEHSA EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EMICEHSA1 EUDAMED
- Basic UDI-DI
- ++EMICFAM1AK2Y9 EUDAMED
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Adhesive system for composite dental restorations and for adhesive luting of dental restorations and braces EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Dentine bonding agent/set
EHSA - ENA Shiny Kit with bond (SE+SHINY) by Micerium S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
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- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
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 | ++EMICFAM1AK2Y9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-PR-000025624
Sources (1)
- EUDAMED ac6f379e-8a02-4573-95cd-2d177e5f8baf 61 fields · synced Jul 9, 2026