Medical device licence · 95309 · Class 3
ARRAY IMAGING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95309
- Licence holder
- Bioarray Solutions Ltd.Warren, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 22, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARRAY IMAGING SYSTEM 400C (AIS)
- ARRAY IMAGING SYSTEM 400D (AIS)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.