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Console Optima Mcx Pink
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1600968-001Model OPTIMA
Identity
- Trade Name
- CONSOLE OPTIMA MCX PINK EUDAMEDOptima MCX pink FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- OPTIMA EUDAMEDOPTIMA consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit FDA UDI
- Model / Reference
- OPTIMA EUDAMED1600968-001 EUDAMEDFDA UDI
- Description
- OPTIMA consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit FDA UDI
Identifiers
- Catalog Number
- 1600968-001 FDA UDI
- Primary DI / UDI-DI
- J00716009680011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007OPTI00012D EUDAMED
- Direct Marketing DI
- J00716009680011 EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Console Optima Mcx Pink by Bien-Air Dental SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++J007OPTI00012D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED c20294d2-cbdf-4778-94ff-de8fdc510f5d 61 fields · synced Jun 19, 2026
- FDA UDI f43b427a-d79f-40be-89fe-de094025c4c6 35 fields · synced May 29, 2026