Identity
- Trade Name
- Elite EUDAMED
- Device Name
- Dental Endodontics Instruments EUDAMED
- Model / Reference
- ED-025-033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G359ED0250330S EUDAMED
- Basic UDI-DI
- ++G359DEndodonticsInstBM EUDAMED
- Direct Marketing DI
- +G359ED0250330S EUDAMED
- EMDN Code
- L159012 ENDODONTIC SPREADERS AND PLUGGERS, 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 | ++G359DEndodonticsInstBM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medixdent International
- EUDAMED SRN
- PK-MF-000027173
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 098f22a7-f564-41e5-966f-456db9acab52 61 fields · synced Jun 20, 2026