Identity
- Device Name
- Light Cure Dental Adhesive EUDAMED
- Model / Reference
- 6ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06909412331976 EUDAMED
- Basic UDI-DI
- 697222048LCA2A01AM EUDAMED
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS 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: Dentine bonding agent/set
Light Cure Dental Adhesive 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 | 697222048LCA2A01AM | 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 bdf53014-7632-464a-a088-3bd6ba56d4ff 61 fields · synced Oct 7, 2026