Medical device licence · 88796 · Class 3
R100 VENTILATOR SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed May 8, 2012; ended October 31, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 88796
- Licence holder
- Metran Co., Ltd.Kawaguchi-Shi, 11, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 8, 2012
- Ended
- October 31, 2019
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- R100 PATIENT SET
- R100 VENTILATOR SYSTEM - ADULT TEST LUNG
- R100 VENTILATOR SYSTEM - DIAPHRAGM CHAMBER
- R100 VENTILATOR SYSTEM - EXPIRATORY BACTERIA FILTER
- R100 VENTILATOR SYSTEM - FIO2 SENSOR
- R100 VENTILATOR SYSTEM - FIO2 SENSOR CABLE
- R100 VENTILATOR SYSTEM - FIO2 T-ADAPTER
- R100 VENTILATOR SYSTEM - IMPEDANCE VALVE
- R100 VENTILATOR SYSTEM - MAIN UNIT
- R100 VENTILATOR SYSTEM - SUPPORT ARM
- R100 VENTILATOR SYSTEM - WATER POLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.