Identity
- Trade Name
- impression trays L2 EUDAMED
- Device Name
- Impression Tray EUDAMED
- Model / Reference
- Z04S EUDAMEDL2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05999133308846 EUDAMED
- Basic UDI-DI
- 59991333ImpressionTrayTM EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
impression trays L2 by Zirconia Dent Company Ltd — 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 | 59991333ImpressionTrayTM | Class I | Active |
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Manufacturer
- Manufacturer
- Zirconia Dent Company Ltd
- EUDAMED SRN
- PK-MF-000034853
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED ec8827bb-6f3c-4fa6-86ff-4d3b365ce7d7 61 fields · synced Jun 18, 2026