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Q-Core Syringable Shade A3
EUDAMEDClass IIa (EU MDR)
Ref 100901ITRef 100901Ref 100901ADA3RORef 100901SA
Identity
- Trade Name
- Q-Core Syringable Shade A3 EUDAMED
- Device Name
- Restoratives- Core Build Up Material EUDAMED
- Model / Reference
- 100901IT EUDAMED100901 EUDAMED100901ADA3RO EUDAMED100901SA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115050851 EUDAMED07290115050233 EUDAMED07290115050967 EUDAMED07290115053982 EUDAMED
- Basic UDI-DI
- 7290115051001008X EUDAMED
- Unit of Use DI
- 07290115053302 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 Syringable 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 (4)
- EUDAMED 694cbe37-b566-4b82-b47b-01de7cc0c697 61 fields · synced Jul 20, 2026
- EUDAMED d90113a0-e4e0-41d9-88b8-c6c6a11b83c2 61 fields · synced May 17, 2026
- EUDAMED 4077233f-93db-4c56-a358-79d917730f6f 61 fields · synced May 18, 2026
- EUDAMED 28305df4-169e-40ca-89d9-3130a33028ca 61 fields · synced May 19, 2026