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Zirconia Block
EUDAMEDClass IIa (EU MDR)
Ref Gradient Multilayer(GM)/98×20mm/A1-3D/1*1Model High Translucency (HT), Anterior Translucency (AT), High Strength (HS), Multi-layered High Translucency (MHT), High Translucency Plus (HT PLUS), Gradient Multilayer (GM), MaxMultilayer-4D (MM-4D)
Identity
- Device Name
- Zirconia Block EUDAMED
- Model / Reference
- High Translucency (HT), Anterior Translucency (AT), High Strength (HS), Multi-layered High Translucency (MHT), High Translucency Plus (HT PLUS), Gradient Multilayer (GM), MaxMultilayer-4D (MM-4D) EUDAMEDGradient Multilayer(GM)/98×20mm/A1-3D/1*1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06909412168299 EUDAMED
- Basic UDI-DI
- 6909412YHG2A01XN EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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 Block by Shandong Huge Dental Material Corporation — 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 | 6909412YHG2A01XN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Huge Dental Material Corporation
- EUDAMED SRN
- CN-MF-000013266
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED c04bdd17-6e48-45eb-aa99-a5f786a6da05 61 fields · synced Oct 6, 2026