Identity
- Trade Name
- Clinix Gel Etch EUDAMED
- Device Name
- Tooth Surface Treatments EUDAMED
- Model / Reference
- 3134108 EUDAMED3134110 EUDAMED3134112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665318006891 EUDAMED03665318006877 EUDAMED03665318006853 EUDAMED
- Basic UDI-DI
- 7290115051000909M EUDAMED
- Unit of Use DI
- 03665318012663 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS 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 etching solution
Clinix Gel Etch by B.J.M. Laboratories Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
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- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
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 | 7290115051000909M | 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 8bd1f0df-1bc1-4df2-9cb3-c0db19619470 61 fields · synced Jul 31, 2026
- EUDAMED 2e860c3d-6c01-4206-8363-d2e8b8abd335 61 fields · synced May 17, 2026
- EUDAMED 81baa603-0f63-4c4c-80c8-bf73430cbbd6 61 fields · synced May 18, 2026