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High-Q-Bond Band
EUDAMEDClass IIa (EU MDR)
Ref 400066SARef 400062Ref 400066Ref 400066RO
Identity
- Trade Name
- High-Q-Bond Band EUDAMED
- Device Name
- Orthodontics (excluding primer) EUDAMED
- Model / Reference
- 400066SA EUDAMED400062 EUDAMED400066 EUDAMED400066RO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115053906 EUDAMED07290115050059 EUDAMED07290115050073 EUDAMED07290115051148 EUDAMED
- Basic UDI-DI
- 729011505400060AK EUDAMED
- Unit of Use DI
- 07290115053371 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 Band 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 (4)
- EUDAMED a0434c30-6d6e-4fe2-8b38-45d16ab48ed6 61 fields · synced Aug 1, 2026
- EUDAMED 1e3c9348-8fea-4a83-9194-bb0fcc44c309 61 fields · synced May 17, 2026
- EUDAMED 4acbba84-6188-4ddb-87dc-ecfd848b5f41 61 fields · synced May 18, 2026
- EUDAMED fc645e85-6842-41ee-a497-06303da75c7d 61 fields · synced May 19, 2026