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ET1H KIT OFFER Ena HRi Tender
EUDAMEDClass IIa (EU MDR)
Ref ET1H-OFModel ENAMEL PLUS HFO acces. Kit
Identity
- Trade Name
- ET1H KIT OFFER Ena HRi Tender EUDAMED
- Device Name
- ENAMEL PLUS HFO acces. Kit EUDAMED
- Model / Reference
- ENAMEL PLUS HFO acces. Kit EUDAMEDET1H-OF EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICET1HOF1 EUDAMED
- Basic UDI-DI
- ++EMICFAM1AE7XZ EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Direct and indirect dental aesthetic restorations on anterior and posterior teeth and for adhesive luting" EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Dental composite resin
ET1H KIT OFFER Ena HRi Tender by Micerium S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++EMICFAM1AE7XZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-PR-000025624
Sources (1)
- EUDAMED c49c3cfd-8f81-446e-b73c-eecd4baf4845 61 fields · synced Jul 15, 2026