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Zirconite
EUDAMEDClass IIa (EU MDR)
Ref 400050TRRef 400050PRORef 400050Ref 400050WRef 400050TRSARef 400050TRPRORef 400050TRGRC
Identity
- Trade Name
- Zirconite EUDAMED
- Device Name
- Permanent Adhesive Cements EUDAMED
- Model / Reference
- 400050TR EUDAMED400050PRO EUDAMED400050 EUDAMED400050W EUDAMED400050TRSA EUDAMED400050TRPRO EUDAMED400050TRGRC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115050394 EUDAMED07290115051018 EUDAMED07290115050387 EUDAMED07290115053067 EUDAMED07290115053838 EUDAMED07290115051025 EUDAMED07290115053494 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
Zirconite 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 c9d13a0c-3ac1-4011-a5c2-e1ab24819e63 61 fields · synced Jul 29, 2026
- EUDAMED 38ef908b-2d34-47e8-bb0f-ee0c6ea85907 61 fields · synced May 16, 2026
- EUDAMED 09151c7d-0403-4233-a5ab-66a2f66d5aec 61 fields · synced May 17, 2026
- EUDAMED 7fb7ad1c-5823-400a-93e9-cb4ead62cb1a 61 fields · synced May 18, 2026
- EUDAMED 81dbcff1-6e5b-4665-8fb3-756da3210c2d 61 fields · synced May 18, 2026
- EUDAMED 4449c326-4884-41ce-9be9-df37706f263f 61 fields · synced May 18, 2026
- EUDAMED c6ef75ae-cb93-4bfb-a2be-5956259a0490 61 fields · synced May 19, 2026