Identity
- Trade Name
- ENA MATRIX 3,5mm 50pcs EUDAMED
- Device Name
- ENA MATRIX EUDAMED
- Model / Reference
- EM35V3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EMICEM35V31E EUDAMED
- Basic UDI-DI
- ++EMICFAM1HVM EUDAMED
- Unit of Use DI
- +EMICEM350M EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class I 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
ENA MATRIX 3, 5mm 50pcs by Micerium S.p.A. — 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 | ++EMICFAM1HVM | Class I | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (1)
- EUDAMED 9a8429bd-a525-471f-a330-8caae8f82208 61 fields · synced Jul 9, 2026