Identity
- Trade Name
- Clinix Cliniseal Quick EUDAMED
- Device Name
- Restoratives- Pit & Fissure Sealtant EUDAMED
- Model / Reference
- 3134116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665318006815 EUDAMED
- Basic UDI-DI
- 72901150510012095 EUDAMED
- Unit of Use DI
- 03665318012670 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER 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
Clinix Cliniseal Quick 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 | 72901150510012095 | 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 360f8cd4-eb0d-451c-9437-cf68040ef7f7 61 fields · synced Jun 19, 2026