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High-Q-Bond Bracket Adhesive
EUDAMEDClass IIa (EU MDR)
Ref 400063ITRef 400063SARef 400063 -X4ITRef 400063RORef 400063 X4Ref 400063 X4 ES
Identity
- Trade Name
- High-Q-Bond Bracket Adhesive EUDAMED
- Device Name
- Orthodontics (excluding primer) EUDAMED
- Model / Reference
- 400063IT EUDAMED400063SA EUDAMED400063 -X4IT EUDAMED400063RO EUDAMED400063 X4 EUDAMED400063 X4 ES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115051544 EUDAMED07290115054019 EUDAMED07290115051537 EUDAMED07290115051124 EUDAMED07290115053593 EUDAMED07290115053555 EUDAMED
- Basic UDI-DI
- 729011505400060AK EUDAMED
- Unit of Use DI
- 07290115053364 EUDAMED
- EMDN Code
- Q010407 ORTHODONTIC CEMENTS 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
High-Q-Bond Bracket Adhesive 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 | 729011505400060AK | 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 (6)
- EUDAMED 54553ed3-8760-41ac-af7f-cb706173e3d9 61 fields · synced Jul 21, 2026
- EUDAMED 1bc163f4-e77a-43c9-afff-8f1c45a6794d 61 fields · synced May 17, 2026
- EUDAMED 254514b4-6843-46fb-9cab-25ea38499edf 61 fields · synced May 17, 2026
- EUDAMED 29f9a502-28c1-4255-9d68-d3a7aba61918 61 fields · synced May 17, 2026
- EUDAMED a1fb5efe-f658-4d7c-b35e-45b2f606cc62 61 fields · synced May 18, 2026
- EUDAMED 1353ac26-6005-49c4-8648-25b1d1019421 61 fields · synced May 19, 2026