Medical device licence · 98051 · Class 2
MORCELLATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98051
- Licence holder
- Trokamed GmbhGeisingen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 18, 2016
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CUTTING MODULE
- FLEXIBLE SHAFT
- FOOT PEDAL
- GRIP MODULE
- MORCELLATOR SYSTEM
- OPERATING AND CONTROL UNIT
- POWER CABLE
- PROTECTIVE SLEEVE ABDOMINAL
- PROTECTIVE SLEEVE TRANSVAGINAL
- VALVE MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.