Medical device licence · 116163 · Class 2
DENTAL ROOT-CANAL INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 10, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 116163
- Licence holder
- Shanwei Perfect Medical Instruments Co., Ltd.Shanwei, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 10, 2026
- Devices covered
- 67
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLUE MASTER ONE
- C-MOVING
- DH FILES
- DK FILES
- DK GOLD
- ENDOSTEP
- ET FILES
- EX FILES
- FLEXIS
- GLIDERS
- GOLD MASTER ONE
- GOLD TAPER XF
- GP FILES
- I-FILE X
- K ONE
- KIDDO
- MAXIS
- MF
- MG3
- MG3 BLUE
- MG3 GOLD
- MG3 LITE
- MG3 WHIZ
- MONO
- MONO GOLD
- MONO MINI
- MONO2
- MT BLUE
- MT FILES
- MT GOLD
- MTF
- MTF PLUS
- MTF PLUS(GOLD)
- NEXIS A-TAPER
- NEXIS I-TRIPLE
- NEXIS R-MOVE
- NX FILES PRO
- PERFECT SHAPE
- PTX ONE
- PX ONE
- PX WAVE
- RC
- RC BLUE
- RC GOLD
- RETREATY KIT
- RS GOLD
- RT FILES
- RT GOLD
- S BLACK
- S BLUE
- S BLUE II
- SUPER SYSTEM
- T-ENDO MUST
- T-FLEX
- T-ONE
- T-PRO
- TF3
- TF3 GOLD
- TF4
- TG6
- TH6
- THE X FILE
- TS3
- TS4
- UNI-FLEX
- UNITAPER
- V BLUE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.