Identity
- Trade Name
- Elite EUDAMED
- Device Name
- Amalgam Carvers EUDAMED
- Model / Reference
- ED-025-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G359ED0251500S EUDAMED
- Basic UDI-DI
- ++G359AmalgamCarversKE EUDAMED
- Direct Marketing DI
- +G359ED0251500S EUDAMED
- EMDN Code
- L159017 DENTAL RESTORATION CARVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Elite by Medixdent International — 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 | ++G359AmalgamCarversKE | Class I | Active |
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Manufacturer
- Manufacturer
- Medixdent International
- EUDAMED SRN
- PK-MF-000027173
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d0948578-be73-45b5-872e-836a47dc7792 61 fields · synced Jun 20, 2026