Medical device licence · 101263 · Class 3
ESTELITE UNIVERSAL FLOW
Yes: licensed in Canada
Licence status Issued (active); first licensed June 20, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101263
- Licence holder
- Tokuyama Dental CorporationTokyo, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 20, 2018
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ESTELITE UNIVERSAL FLOW HIGH PLT
- ESTELITE UNIVERSAL FLOW HIGH SYR
- ESTELITE UNIVERSAL FLOW MEDIUM PLT
- ESTELITE UNIVERSAL FLOW MEDIUM S-SYR
- ESTELITE UNIVERSAL FLOW MEDIUM SYR
- ESTELITE UNIVERSAL FLOW SUPERLOW PLT
- ESTELITE UNIVERSAL FLOW SUPERLOW SYR
- OMNICHROMA BLOCKER FLOW SYRINGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.