Medical device licence · 92090 · Class 2
INSIGHT ULTIMA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 9, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92090
- Licence holder
- Diversatek HealthcareHighlands Ranch, CO, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 9, 2013
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 400CC TPE BALLOONS FOR HRAM CATHETERS
- DISPOSABLE SUTURE KIT FOR ANORECTAL BALLOONS
- INSIGHT ULTIMA BASE CART SYSTEM
- INSIGHT ULTIMA BASE SYSTEM
- INSIGHT ULTIMA CENTRAL UNIT
- INSIGHT ULTIMA MANOMETRY SYSTEM
- INSIGHT ULTIMA SYSTEM
- KIT, INCLUDES BALLOON, POLYURETHANE BANDS AND DISPOSABLE SUTURE REMOVAL KITS
- LIGATOR FOR ANORECTAL BALLOONS
- POLYURETHANE BANDS
- ULTIMA CENTRAL UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.