Identity
- Device Name
- Universal Composite Restorative EUDAMED
- Model / Reference
- OA1/4g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06909412345027 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
Category: Dental composite resin
Universal Composite Restorative 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 | 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 5a9c84b0-810c-49b5-b8bf-eb1eda696f2b 61 fields · synced Oct 6, 2026