Elite
by Medixdent International 1,000+ variants
Ref ED-140
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G359BracHeightGauge8D +G359ED1400K | Date18 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- Withdrawn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
- Bracket Height Gauge
- Model / reference
- ED-140
- Primary DI / UDI-DI
- +G359ED1400K
- Basic UDI-DI
- ++G359BracHeightGauge8D
- Direct marketing DI
- +G359ED1400K
- EMDN code
- L15901102 Dam positioning instruments, reusable
- Device class
- Class I
- EU registration type
- Standard device
- 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)
- Supplied sterile: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No