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Dentalica Precision One-Q Bond C.G.T SE
EUDAMEDClass IIa (EU MDR)
Ref PR0062OSE
Identity
- Trade Name
- Dentalica Precision One-Q Bond C.G.T SE EUDAMED
- Device Name
- Bonding Agents EUDAMED
- Model / Reference
- PR0062OSE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057502150070 EUDAMED
- Basic UDI-DI
- 72901150510020094 EUDAMED
- Unit of Use DI
- 08057502150964 EUDAMED
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS 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
Dentalica Precision One-Q Bond C.G.T SE by B.J.M. Laboratories Ltd. — 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 | 72901150510020094 | 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 (1)
- EUDAMED 033c8c67-e67e-412e-acab-6ef161239b5a 61 fields · synced Oct 7, 2026