Medical device licence · 63937 · Class 2
TRUCLEAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 10, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 63937
- Licence holder
- Covidien LlcChicopee, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 10, 2004
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLUID MONITOR
- HYSTEROSCOPIC TUBE SETS
- MANAGEMENT CONTROL UNIT
- TRUCLEAR DENSE TISSUE SHAVER PLUS
- TRUCLEAR SOFT TISSUE SHAVER MINI
- TRUCLEAR SOFT TISSUE SHAVER PLUS
- TRUCLEAR SYSTEM - CALIBRATION INSERT
- TRUCLEAR SYSTEM - FOOTSWITCH
- TRUCLEAR SYSTEM - HYSTEROSCOPE OBTURATOR
- TRUCLEAR SYSTEM - HYSTEROSCOPE SHEATH
- TRUCLEAR SYSTEM- CONTROL UNIT
- TRUCLEAR SYSTEM- HANDPIECE
- TRUCLEAR ULTRA MINI
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.