Medical device licence · 1540 · Class 2
DIGITRAPPER
Yes: licensed in Canada
Licence status Issued (active); first licensed February 23, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 1540
- Licence holder
- Given Imaging, Inc.Mansfield, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 23, 1999
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALIBRATION ACCESSORIES
- DIGITRAPPER PH-Z - RECORDER
- REFLUX SOFTWARE V6.0
- REFLUX SOFTWARE V6.0 UPGRADE
- REFLUX SOFTWARE V6.1
- REFLUX SOFTWARE V6.1 UPGRADE
- VERSAFLEX CATHETER, LPR STARTER KIT
- VERSAFLEX DISPOSABLE PH CATHETER
- VERSAFLEX-Z DISPOSABLE PH/IMPEDANCE CATHETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.