Medical device licence · 84424 · Class 2
PHYSICAL EVALUATION AND FUNCTIONAL TESTING BASE KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 15, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84424
- Licence holder
- Jtech Medical Industries, Inc.Midvale, UT, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 15, 2010
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BASE KIT, COMMANDER ECHO
- ECHO BASE KIT
- EVAL EXPRESS BASE KIT
- NORTHSTAR BASE KIT
- TRACKER FREEDOM BASE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.