Medical device licence · 81341 · Class 2
ELECTROMAGNETIC TRACKING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 1, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81341
- Licence holder
- Civco Medical Instruments Co., Inc.Kalona, IA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- December 1, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ETRAX NEEDLE REPLACEMENT KIT
- ETRAX NEEDLE STARTER KIT
- OMNITRAX ACTIVE PATIENT TRACKER STARTER KIT
- OMNITRAX PATIENT TRACKER
- TRACKING BRACKET KIT
- VERZA GUIDANCE SYSTEM
- VIRTUTRAX KIT
- VNAV KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.