Medical device licence · 110795 · Class 2
ROOT ZX3
Yes: licensed in Canada
Licence status Issued (active); first licensed February 7, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110795
- Licence holder
- J. Morita Manufacturing Corp.Kyoto, 26, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 7, 2024
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BATTERY PACK
- CONTRARY ELECTRODES
- CUTTING ELECTRODE NO. 1
- ELECTRODE C #10
- ELECTRODE C #25
- ELECTRODE HOLDER
- ELECTRODE PEN
- ELECTRODE S #25L25
- ELECTRODE S #40L25
- ELECTRODE S#10L25
- FILE HOLDERS
- GRIP
- LONG FILE HOLDERS
- PROBE CORD
- ROOT ZX3: APEX LOCATOR
- ROOT ZX3: HF MODULE
- UNCOATED ELECTRODE S #10L25
- UNCOATED ELECTRODE S #25L25
- UNCOATED ELECTRODE S #40L25
- WIDE CONTRARY ELECTRODE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.