Medical device licence · 72341 · Class 2
SOLAR SMARTFLOW URODYNAMICS SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed September 13, 2006; ended April 5, 2013. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 72341
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 13, 2006
- Ended
- April 5, 2013
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOLAR SMARTFLOR URODYNAMICS SYSTEM - GREY (DIGITAL PORT) CONNECTOR CABLES
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - CIM (CATHETER INTERFACE MODULE)
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - CYSTOMETRY CATHETER
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - DISPOSABLE EMG SURFACE ELECTRODES
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - DOMES FOR REUSABLE MEMSCAP TRANSDUCER
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - EMG CABLE
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - EXTENSION LINE
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - INTEGRATED KEYBOARD AND MOUSE
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - INTERFACE CABLE FOR SINGLE-USE TRANS.
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - MAIN HUB
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - MAIN UNIT
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - MEMSCAP REUSABLE WATER TRANSDUCER
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - MICROTIP CATHETER
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - MICROTIP INTERFACE CABLE
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - MONITOR
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - PRESSURE CUFF FOR UPP/LES PERFUSION
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - PUMP
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - PUMP TUBING
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - RECTAL BALLOON CATHETER
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - SINGLE-USE DISP. PRESSURE TRANSDUCER
- SOLAR SMARTFLOW URODYNAMICS SYSTEM - UPP FLOW REDUCER SET
- SOLAR SMARTFLOW URODYNAMICS SYSTEM- POWER CORD FOR U2M
- SOLAR SMARTFLOW URODYNAMICS SYSTEM- URETHRAL PRESSURE PROFILE SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.