Medical device licence · 97198 · Class 2
HYBERNITE RT
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed June 25, 2016; ended October 31, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 97198
- Licence holder
- Plastiflex Group N.V. Also Doing Business As Plastiflex HealthcarePaal-Beringen, Belgium
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 25, 2016
- Ended
- October 31, 2018
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLASSIC RT 15
- CLASSIC RT 19
- EXPIRATORY CAIRMAX 15
- HYBERNITE RT 1000
- HYBERNITE RT 1100
- HYBERNITE RT 2000
- HYBERNITE RT 2100
- HYBERNITE RT 3000
- HYBERNITE RT 3000 CON
- HYBERNITE RT 3000 EXP
- HYBERNITE RT 3000 INS+INC
- HYBERNITE RT 3100
- INSPIRATORY CAIRMAX 15
- PHBT EX 850
- PHBT INS 850
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.