Identity
- Trade Name
- VinciSmile EUDAMED
- Device Name
- Invisible Orthodontic Appliance EUDAMED
- Model / Reference
- LX-A EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970402679316 EUDAMED
- Basic UDI-DI
- 6909412JZQ2A012J EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
VinciSmile 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 | 6909412JZQ2A012J | 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 17dbd1c8-a483-4f41-ac9a-19adeb13df1c 61 fields · synced Jun 18, 2026
- EUDAMED 58132f5b-1965-44e5-a352-fa1fc024839f 61 fields · synced Jun 18, 2026