Medical device licence · 68494 · Class 3
OPERA
Yes: licensed in Canada
Licence status Issued (active); first licensed May 27, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 68494
- Licence holder
- General Medical Merate S.P.A.Seriate, BG, Italy
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 27, 2005
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPERA X-RAY SYSTEM - ANALOG IMAGING SYSTEM
- OPERA X-RAY SYSTEM - COLLIMATORS
- OPERA X-RAY SYSTEM - DIGITAL IMAGING SYSTEM
- OPERA X-RAY SYSTEM - IMAGE INTENSIFIER
- OPERA X-RAY SYSTEM - MAIN UNIT
- OPERA X-RAY SYSTEM - WALL BUCKY STANDS
- OPERA X-RAY SYSTEM - X-RAY GENERATORS
- OPERA X-RAY SYSTEM - X-RAY TABLES
- OPERA X-RAY SYSTEM - X-RAY TUBE ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.