Medical device licence · 109097 · Class 2
MORPHEUS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 21, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109097
- Licence holder
- The Prometheus GroupDover, NH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 21, 2023
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 10 FOOT DIGITAL YOKE ASSEMBLY CABLE
- AIR-CHARGED REUSABLE CABLE
- CH A 10 FOOT INTERFACE CABLE FOR 7400 DISPOSABLE LEAD WIRE ELECTRODES
- CHANNEL B EXTENDED PATHWAY PREAMPLIFIER
- DISPOSABLE LEAD WIRE ELECTRODES
- GAME OPTION
- MORPHEUS ANORECTAL MANOMETRY WITH PARADOXICAL SEMG
- MORPHEUS CONTROL MODULE
- MORPHEUS PELVIC MUSCLE REHABILITATION SYSTEM
- MORPHEUS TWO CHANNEL EMG WITH STIMULATION
- MORPHEUS UHD ADVANCED URODYNAMICS
- MORPHEUS URODYNAMICS
- MORPHEUS UROFLOWMETRY
- MORPHEUS VIDEO URODYNAMICS
- PATHWAY ELECTRODES
- PATHWAY RECTAL SEMG/STIMULATION SENSOR
- PATHWAY VAGINAL SEMG/STIMULATION SENSOR
- PUMP TUBING
- QUADRANT AIR-CHARGED REUSABLE CABLE
- RECTAL PRESSURE SENSOR
- WATER PERFUSED REUSABLE CABLE
- WIFLOW UROFLOWMETRY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.