Identity
- Trade Name
- Elite EUDAMED
- Device Name
- Dental Amalgam Carriers EUDAMED
- Model / Reference
- ED-200-092 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G359ED2000920S EUDAMED
- Basic UDI-DI
- ++G359DAmalgamCarriersW5 EUDAMED
- Direct Marketing DI
- +G359ED2000920S EUDAMED
- EMDN Code
- Q01010101 AMALGAMS FOR RESTORATIVE DENTISTRY 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 | ++G359DAmalgamCarriersW5 | 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 f68f59f3-65bf-43cb-bcc1-faf044c84b4c 61 fields · synced Jun 18, 2026