Elite
by Medixdent International 1,000+ variants
Ref ED-225-045S
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G359ImpressionTrays5Z +G359ED225045S0I | Date20 May 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Impression Trays
- Model / Reference
- ED-225-045S
- Primary DI / UDI-DI
- +G359ED225045S0I
- Basic UDI-DI
- ++G359ImpressionTrays5Z
- Direct Marketing DI
- +G359ED225045S0I
- EMDN Code
- Q010207 Dental impression devices for prosthetic dentistry
- Device Class
- Class I
- EU 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