Identity
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- MDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978021230833 EUDAMED
- Basic UDI-DI
- 697802123DECMEDZ EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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: Silicone dental impression material
Zirconia Dental Ceramics by De Corematrix Co., Ltd. — Class IIa — 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 | 697802123DECMEDZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- De Corematrix Co., Ltd
- EUDAMED SRN
- CN-MF-000025755
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED e95882bf-9f58-4c0b-b772-6c2e4e250f7b 61 fields · synced Jun 19, 2026