Identity
- Model / Reference
- TEMP EUDAMEDTEMP10UD3,5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICTEMP10UD351 EUDAMED
- Basic UDI-DI
- ++EMICFAM439 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Temp10ud3 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 | ++EMICFAM439 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (2)
- EUDAMED 496466b3-f326-49e8-82f2-59220d1ce1fc-1 61 fields · synced Jul 19, 2026
- EUDAMED 496466b3-f326-49e8-82f2-59220d1ce1fc-2 61 fields · synced Jul 19, 2026