Medical device licence · 105326 · Class 2
MIVU MUCOSAL INTEGRITY TESTING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 20, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105326
- Licence holder
- Diversatek HealthcareHighlands Ranch, CO, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 20, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MIVU CABLE
- MIVU ENDO CAP CABLE
- MIVU ESOPHAGEAL ENDO CAP
- MIVU INFLATION SYRINGE AND EXTENSION TUBING
- MIVU MUCOSAL INTEGRITY BALLOON PROBE
- MIVU REGULATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.