Elite
by Medixdent International EUDAMED
Active
Ref ED-200-093A
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G359DAmalgamCarriersW5 | Date18 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Dental Amalgam Carriers
- Model / Reference
- ED-200-093A
- Primary DI / UDI-DI
- +G359ED200093A0$
- Basic UDI-DI
- ++G359DAmalgamCarriersW5
- Direct Marketing DI
- +G359ED200093A0$
- EMDN Code
- Q01010101 Amalgams for restorative dentistry
- 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
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