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Console MEG-ENGINE II
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1601100-001Model CHIROPRO
Identity
- Trade Name
- Console MEG-ENGINE II EUDAMEDFDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- CHIROPRO EUDAMEDMEG-ENGINE II is an electrical medical device used to run dental instruments FDA UDI
- Model / Reference
- CHIROPRO EUDAMED1601100-001 EUDAMEDFDA UDI
- Description
- MEG-ENGINE II is an electrical medical device used to run dental instruments FDA UDI
Identifiers
- Catalog Number
- 1601100-001 FDA UDI
- Primary DI / UDI-DI
- J00716011000011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007CHIR0001MJ EUDAMED
- Direct Marketing DI
- J00716011000011 EUDAMED
- FDA Product Code
- EBW 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
- 872.4200 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
Console MEG-ENGINE II 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 | ++J007CHIR0001MJ | 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 7fc417cf-880e-46e4-854f-c4a824e24371 61 fields · synced Oct 6, 2026
- FDA UDI c31d84ad-5560-4d33-822d-4ec84e4aa9b6 35 fields · synced May 30, 2026