Identity
- Trade Name
- Elite EUDAMED
- Device Name
- Holloware Instruments EUDAMED
- Model / Reference
- ED-225-069 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G359ED2250690$ EUDAMED
- Basic UDI-DI
- ++G359HollowareInst2S EUDAMED
- Direct Marketing DI
- +G359ED2250690$ EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS 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 | ++G359HollowareInst2S | 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 5a9beb73-dd9d-42a7-b09d-63423ad8f101 61 fields · synced Jun 20, 2026