Medical device licence · 79436 · Class 2
HOLTER RECORDERS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 1, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79436
- Licence holder
- Global Instrumentation, LlcEast Syracuse, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 1, 2009
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HR100 HOLTER RECORDER
- HR1200 HOLTER RECORDER
- HR300 HOLTER RECORDER
- HR300R MINI HOLTER RECORDER
- M12R HOLTER RECORDER
- M3R HOLTER RECORDER
- M5 RECORDER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.