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Cem-Implant
EUDAMEDClass IIa (EU MDR)
Ref 100115GRRef 100115ITRef 100115Ref 100110ITRef 100115SARef 100110
Identity
- Trade Name
- Cem-Implant EUDAMED
- Device Name
- Implant Cement EUDAMED
- Model / Reference
- 100115GR EUDAMED100115IT EUDAMED100115 EUDAMED100110IT EUDAMED100115SA EUDAMED100110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115050783 EUDAMED07290115051285 EUDAMED07290115050301 EUDAMED07290115051278 EUDAMED07290115053944 EUDAMED07290115050295 EUDAMED
- Basic UDI-DI
- 7290115051001159C EUDAMED
- Unit of Use DI
- 07290115053289 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
Cem-Implant 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 | 7290115051001159C | 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 10b1605d-7d48-431d-ab33-57665eef4ebc 61 fields · synced Jul 19, 2026
- EUDAMED 2324aed9-5cdb-4acb-a414-f94026dfd186 61 fields · synced May 17, 2026
- EUDAMED b9ff6e38-4223-4de2-a265-a6dff48d2c61 61 fields · synced May 18, 2026
- EUDAMED 1fbe78a4-bc66-4bb2-8d83-e2a08a65fd74 61 fields · synced May 18, 2026
- EUDAMED 98427707-f812-437a-ac4f-37fc61f6e422 61 fields · synced May 18, 2026
- EUDAMED ed75eed3-44ae-49e0-b41e-a31eb31df5d7 61 fields · synced May 19, 2026