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Console Optima Mx2 Int 104761
EUDAMEDClass IIa (EU MDR)
Ref 1601259-001Model OPTIMA
Identity
- Trade Name
- CONSOLE OPTIMA MX2 INT 104761 EUDAMED
- Device Name
- OPTIMA EUDAMED
- Model / Reference
- OPTIMA EUDAMED1601259-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- J00716012590011 EUDAMED
- Basic UDI-DI
- ++J007OPTI00012D EUDAMED
- Direct Marketing DI
- J00716012590011 EUDAMED
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Console Optima Mx2 Int 104761 by Bien-Air Dental SA — 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 | ++J007OPTI00012D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
- EUDAMED SRN
- CH-MF-000014661
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (1)
- EUDAMED 00c97097-7333-44da-8e9f-ddd2dbfdc65a 61 fields · synced Jun 18, 2026