Elite
by Medixdent International Pakistan EUDAMED
Ref ED-025-147
EMDN L159017
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G359AmalgamCarversKE | Date16 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Amalgam Carvers
- Model / Reference
- ED-025-147
- Primary DI / UDI-DI
- +G359ED0251470Y
- Basic UDI-DI
- ++G359AmalgamCarversKE
- Direct Marketing DI
- +G359ED0251470Y
- EMDN Code
- L159017 Dental restoration carvers, reusable
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- PK-MF-000027173
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Medixdent International
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 444337bc-b1ae-4019-ad26-4732485ea652