Identity
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- SHTML 98D12 A3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974208585178 EUDAMED
- Basic UDI-DI
- 697802123DECMMEH EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - 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
Zirconia Dental Ceramics by De Corematrix Co., Ltd. — Class IIa — 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 | 697802123DECMMEH | 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 57f86d76-982b-43ee-95ee-04414ab9957f 61 fields · synced Jun 19, 2026