Medical device licence · 75488 · Class 2
MANOSCAN SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 1, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 75488
- Licence holder
- Given Imaging, Inc.Mansfield, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 1, 2007
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AR BALLOONS
- ASSY, MANOSCAN CART
- HIGH DEFINITION ANORECTAL CATHETER
- HIGH DEFINITION ESOPHAGEAL CATHETER
- HIGH RESOLUTION ADULT CATHETER
- HIGH RESOLUTION ANORECTAL CATHETER
- HIGH RESOLUTION ESOPHAGEAL CATHETER
- HIGH RESOLUTION ESOPHAGEAL CATHETER WITH IMPEDANCE
- HIGH RESOLUTION PEDIATRIC ANORECTAL CATHETER
- HIGH RESOLUTION PEDIATRIC CATHETER
- MANOSCAN MODULES
- MANOSCAN WORKSTATION ACCESSORIES
- MANOSCAN, MANOVIEW SOFTWARE
- MANOSHIELD 3DAR SANITARY CATHETER SHEATH
- MANOSHIELD AR SANITARY CATHETER SHEATH
- MANOSHIELD SANITARY CATHETER SHEATH
- MANOSHIELD SD SANITARY CATHETER SHEATH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.