Identity
- Trade Name
- Elite EUDAMED
- Device Name
- Band Pusher and Seating Instruments EUDAMED
- Model / Reference
- ED-160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G359ED1600M EUDAMED
- Basic UDI-DI
- ++G359BPAndSeatingInst4X EUDAMED
- Direct Marketing DI
- +G359ED1600M EUDAMED
- EMDN Code
- L150704 ORTHODONTIC BAND PUSHERS, REUSABLE 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 | ++G359BPAndSeatingInst4X | 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 8c28e44a-3d3a-47ba-9564-a24a6bb7c7d6 61 fields · synced Jun 18, 2026