Medical device licence · 92651 · Class 2
RETROFIT KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 21, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 92651
- Licence holder
- Samsung Electronics Co., Ltd.Suwon-Si, GD, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 21, 2014
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUTO LUNG NODULE DETECTION
- CIB
- DIGITAL FLAT PANEL X-RAY DETECTOR
- RETROFIT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.