Identity
- Trade Name
- Impression Trays (U2) EUDAMED
- Device Name
- Impression Tray EUDAMED
- Model / Reference
- Z04S EUDAMEDU2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05999133308792 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
Category: Silicone dental impression material
Impression Trays (U2) by Zirconia Dent Company Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 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 1af250ba-31cd-4c2b-a302-7c5e41fab80a 61 fields · synced Jun 18, 2026