Medical device licence · 38055 · Class 2
EMPOWER INJECTOR SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 15, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 38055
- Licence holder
- Bracco Injeneering S.A.Lausanne, SZ, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- May 15, 2002
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMPOWER 10 USB KEY FOR ONYX 17
- EMPOWER CT INJECTOR SYSTEM WITH CEILING / WALL MOUNT (NO EDA)
- EMPOWER CT WITH FLOOR STAND (NO EDA)
- EMPOWER SYNC. SYS, CEIL / WALL MT W/O EDA
- EMPOWER SYNC. SYS, W/EDA, CEIL / WL MT
- EMPOWER SYNC. SYS, W/EDA, FLR MT
- EMPOWER SYS, FLOOR MOUNT W/O EDA
- EMPOWERCT INJECTOR SYSTEM
- EMPOWERCTA INJECTOR SYSTEM
- EMPOWERCTA INJECTOR SYSTEM - CEILING MOUNT (NO EDA)
- EMPOWERCTA INJECTOR SYSTEM - CEILING MOUNT W/EXTRAVASATION DETECTION
- EMPOWERCTA INJECTOR SYSTEM - PEDESTAL MOUNT W/EXTRAVASATION DETECTION
- EMPOWERCTA INJECTOR SYSTEM - WITH FLOOR STAND (NO EDA)
- EXTRAVASATION DETECTION ACCESSORY (EDA ELECTRODE PATCH)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.