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Q-Etch
EUDAMEDClass IIa (EU MDR)
Ref 100097ITRef 400067SARef 400067Ref 100097Ref 100090
Identity
- Trade Name
- Q-Etch EUDAMEDQ-Etch Ortho EUDAMED
- Device Name
- Tooth Surface Treatments EUDAMED
- Model / Reference
- 100097IT EUDAMED400067SA EUDAMED400067 EUDAMED100097 EUDAMED100090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115050806 EUDAMED07290115054002 EUDAMED07290115050066 EUDAMED07290115050509 EUDAMED07290115050486 EUDAMED
- Basic UDI-DI
- 7290115051000909M EUDAMED
- Unit of Use DI
- 07290115052794 EUDAMED07290115052817 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
Q-Etch 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 | 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 (5)
- EUDAMED cc5d66bd-d0a0-4760-bfc4-51548a4f29e2 61 fields · synced Jul 13, 2026
- EUDAMED 652c40a3-6f8c-40a2-8d60-ee6a9ef89d3e 61 fields · synced May 17, 2026
- EUDAMED 5c5d71fd-ff0b-47c7-841b-e0f50d021029 61 fields · synced May 17, 2026
- EUDAMED 68d2aa54-ef25-4057-97a2-5607526d3f8f 61 fields · synced May 18, 2026
- EUDAMED 1cccb768-6651-4a25-ac1c-4bab9c64e81b 61 fields · synced May 18, 2026