Identity
- Trade Name
- Q-Core Shade A3 EUDAMED
- Device Name
- Restoratives- Core Build Up Material EUDAMED
- Model / Reference
- 100106IT EUDAMED100101 EUDAMED100106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115051247 EUDAMED07290115050264 EUDAMED07290115050288 EUDAMED
- Basic UDI-DI
- 7290115051001008X EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Q-Core Shade A3 by B.J.M. Laboratories Ltd. — 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 | 7290115051001008X | Class IIa | Active |
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Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 0c8bbe50-bc55-4580-abc9-d9a751b86d07 61 fields · synced Jul 20, 2026
- EUDAMED eca9c314-76f1-4fb6-9dec-825cf4206603 61 fields · synced May 17, 2026
- EUDAMED 23558b25-27b1-4a6f-b7d0-7c0ce41aa531 61 fields · synced May 18, 2026