Medical device licence · 69581 · Class 3
PACHPEN
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69581
- Licence holder
- Accutome Inc. AlsoMalvern, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 25, 2005
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PACHPEN - BATTERY
- PACHPEN - MAIN UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.