Medical device licence · 99388 · Class 3
NGSENGINE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 10, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99388
- Licence holder
- Genome Diagnostics B.V.Utrecht, Netherlands
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- July 10, 2017
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NGSENGINE, FIVE YEAR PREMIUM EXTENSION
- NGSENGINE, ONE YEAR STANDARD EXTENSION
- NGSENGINE, PREMIUM ENTRY
- NGSENGINE, STANDARD ENTRY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.