Medical device licence · 116346 · Class 2
INTRAORAL SCANNER (AORALSCAN ELF PRO)
Yes: licensed in Canada
Licence status Issued (active); first licensed October 7, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 116346
- Licence holder
- Shining 3D Tech Co., Ltd.Hangzhou, 130, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 7, 2026
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AGR BIG SCANNER TIP
- AGR BIG TIP BODY
- AGR MINI SCANNER TIP
- AGR MINI TIP BODY
- AGR STANDARD SCANNER TIP
- AGR STANDARD TIP BODY
- BIG TIP
- CALIBRATOR
- CRADLE
- DISPOSABLE TIPS
- FLEXIBLE TUBING
- INTRAORAL SCANNER
- MINI CALIBRATOR
- MINI TIP
- QUICK CONNECTOR
- STANDARD TIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.