Identity
- Trade Name
- Elite EUDAMED
- Device Name
- Impression Trays EUDAMED
- Model / Reference
- ED-225-018S EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G359ED225018S0I EUDAMED
- Basic UDI-DI
- ++G359ImpressionTrays5Z EUDAMED
- Direct Marketing DI
- +G359ED225018S0I EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY 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
Category: Dental implant suprastructure, temporary, preformed, single-use
Elite by Medixdent International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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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 | ++G359ImpressionTrays5Z | Class I | Active |
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Manufacturer
- Manufacturer
- Medixdent International
- EUDAMED SRN
- PK-MF-000027173
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 180f3b24-c519-4c9f-a500-301fc3254c84 61 fields · synced Jun 19, 2026