Medical device licence · 71442 · Class 2
PRODRIVE REPLACEMENT TURBINE
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed May 25, 2006; ended October 12, 2012. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 71442
- Licence holder
- Prodrive Systems Inc.Ogdensburg, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 25, 2006
- Ended
- October 12, 2012
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIRONA T3 MINI
- SIRONA T3 RACER
- TA MIDWEST STYLUS
- TA PD HS KAVO
- TA PD HS KAVO 635
- TA PD HS KAVO BELLA TORQUE
- TA PD HS KAVO SUPER TORQUE
- TA PD HS MIDWEST QUIETAIR LEVER
- TA PD HS MIDWEST TRADITION PB
- TA PD HS PRODRIVE
- TA PD HS PRODRIVE MINI & SIRONA T2 MINI
- TA PD HS PRODRIVE MINI FIXED
- TA PD HS SIRONA
- TA PD HS STAR 430
- TA PD MIDWEST TRADITION LEVER
- TA STAR 430 WITH CERAMIC BEARINGS
- W&H TA 96/97/98
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.