Identity
- Trade Name
- Universal Composite Restorative EUDAMED
- Device Name
- Universal Composite Restorative EUDAMED
- Model / Reference
- C2/4g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06909412330016 EUDAMED
- Basic UDI-DI
- 697222048UCR2A01M9 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES 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
Universal Composite Restorative 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 | 697222048UCR2A01M9 | 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 e891eecc-df26-4fd3-9d98-7d89265b19a1 61 fields · synced Oct 6, 2026