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Zirking
EUDAMEDClass IIa (EU MDR)
Ref N/AModel 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
- Trade Name
- Zirking EUDAMED
- 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) EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06909412123434 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
Category: Dental appliance fabrication material, ceramic
Zirking by Shandong Huge Dental Material Corporation — 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 | 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 (2)
- EUDAMED 3ec0a035-0e6a-4fba-a3ef-56d79a927f13 61 fields · synced Jun 18, 2026
- EUDAMED 3ec0a035-0e6a-4fba-a3ef-56d79a927f13-1 61 fields · synced Jun 10, 2026