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Dental zirconia ceramic
EUDAMEDClass IIa (EU MDR)
Ref STC-D98*12Model Dental zirconia ceramic
Identity
- Trade Name
- Dental zirconia ceramic EUDAMED
- Device Name
- Dental zirconia ceramic EUDAMED
- Model / Reference
- Dental zirconia ceramic EUDAMEDSTC-D98*12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975330310386 EUDAMED
- Basic UDI-DI
- 697533031s01S6 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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: Dental appliance fabrication material, ceramic
Dental zirconia ceramic by HaGong NingBo Medical Technology Taizhou 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 | 697533031s01S6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HaGong NingBo Medical Technology Taizhou Co., Ltd.
- EUDAMED SRN
- CN-MF-000024839
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 17b08aec-5f1f-48ef-a713-d51b8c4ca06d 61 fields · synced Jun 19, 2026