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High-Q-Bond SE
EUDAMEDClass IIa (EU MDR)
Ref 100052SEPRORef 100052SEGRCRef 100050AMADRORef 100050Ref 100050AMGRRef 100051SESARef 100052SESA
Identity
- Trade Name
- High-Q-Bond SE EUDAMEDHigh-Q-Bond EUDAMED
- Device Name
- Permanent Adhesive Cements EUDAMED
- Model / Reference
- 100052SEPRO EUDAMED100052SEGRC EUDAMED100050AMADRO EUDAMED100050 EUDAMED100050AMGR EUDAMED100051SESA EUDAMED100052SESA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115051032 EUDAMED07290115053890 EUDAMED07290115051001 EUDAMED07290115050363 EUDAMED07290115053081 EUDAMED07290115053852 EUDAMED07290115053869 EUDAMED
- Basic UDI-DI
- 72901150510005099 EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - 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
Category: Dental composite resin
High-Q-Bond SE 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 | 72901150510005099 | 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 (7)
- EUDAMED ed0c175f-76e9-41f5-841a-643d127a4583 61 fields · synced Jul 26, 2026
- EUDAMED 9642866b-0f99-4f43-8cfc-fcbdf0493f91 61 fields · synced May 16, 2026
- EUDAMED e626e2e0-e251-4059-92a4-c797a02670a0 61 fields · synced May 17, 2026
- EUDAMED 899052e8-90e3-4502-88ad-1df8a060fb07 61 fields · synced May 17, 2026
- EUDAMED 66fce064-3875-41c4-9484-c542928bdc38 61 fields · synced May 17, 2026
- EUDAMED ad572a44-84d8-4929-a34b-58e35d7f269f 61 fields · synced May 18, 2026
- EUDAMED bfe9f010-6de1-4027-9fae-c76e96436fbf 61 fields · synced May 18, 2026